|
Device |
transmitters and receivers, physiological signal, radiofrequency |
Product Code | DRG |
Regulation Number |
870.2910
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
3M COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
AFRAME DIGITAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ALCATEL-LUCENT CANADA INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ALIO, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ARRAYENT HEALTH LLC D/B/A AMBIO HEALTH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ASCOT TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOCOMFORT DIAGNOSTICS GMBH & CO. KG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOINTELLISENSE INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOLNTELLISENSE INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BL HEALTHCARE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BOSTON SCIENTIFIC CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BRAVEHEART WIRELESS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARDIOCOM LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARDIOLINE S.P.A |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CAREFUSION 303, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CAREMATIX INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARETAKER MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CELLCO PARTNERSHIP D/B/A VERIZON WIRELESS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CELLO PARTNERSHIP D/B/A VERIZON WIRELESS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CERNER CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COMARCH HEALTHCARE SA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONFIDANT INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONSTANT CARE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CONTINUITY HEALTH SOLUTIONS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DIGIO2 INTERNATIONAL CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ELASTIC CARE INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ELCAM MEDICAL A.C.A.L. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EMERGO EUROPE CONSULTING BV |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENTRA HEALTH SYSTEMS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ERGOLINE GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EXPRESS MD SOLUTIONS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GRAFTWORX, INC. DBA ALIO |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HEALTHANYWHERE, AN IGEACARE SYSTEM COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HEALTHINTERLINK, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HMICRO, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HONEYWELL HOMMED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HONEYWELL HOMMED, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
HOSPIRA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IMETRIKUS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INTEL CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INTEL CORPORATION DIGITAL HEALTH GROUP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INTEL-GE CARE INNOVATIONS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
INTOUCH HEALTH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ISANSYS LIFECARE LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LG ELECTRONICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIFELINE SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIFESIGNALS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
LR MED INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MC10 INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDAPPS INC., DBA ALERE CONNECT |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDAPPS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDICOMP, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MORTARA INSTRUMENT INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MORTARA INSTRUMENT, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NIHON KOHDEN CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OPTUMHEALTH CARE SOLUTIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHILIPS MEDICAL SYSTEMS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
POLYMAP WIRELESS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ROOTI LABS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SAMSUNG ELECTRONICS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SANITAS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SIBEL HEALTH INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SIBEL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SIGKNOW BIOMEDICAL CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ST. JUDE MEDICAL SYSTEMS AB |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SYNERGEN TECHNOLOGY LABS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TAIDOC TECHNOLOGY CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TELEMEDCARE PTY LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TUNSTALL HEALTHCARE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
UNITED HEALTH GROUP INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VIGNET INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VISICU INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VISICU, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VITAL CONNECT INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VITAL CONNECT, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VITAL CONNECT, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
VITALCONNECT, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
VITLS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VIVALNK, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VIVIFY HEALTH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VOCARE, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WALDO HEALTH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WATERMARK MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ZEPHYR TECHNOLOGY CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|