|
Device |
spirometer, diagnostic |
Product Code | BZG |
Regulation Number |
868.1840
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ALERKAN LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BENSON MEDICAL INSTRUMENTS CO. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIONET CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARDINAL HEALTH GERMANY 234 GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CAREFUSION GERMANY 234 GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
CHEST M.I., INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
COHERO HEALTH LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COSMED S.R.L. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ERESEARCH TECHNOLOGY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ERESEARCHTECHNOLOGY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FEELLIFE HEALTH INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FIM MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GANSHORN MEDIZIN ELECTRONIC GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INNOVISION A/S |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INOFAB SAGLIK TEKNOLOJILERI A.S |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
1. K213754 SpiroHome Personal, SpiroHome Clinic
|
MEDICAL INTERNATIONAL RESEARCH USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDICAL RESPIRATORY DEVICES S.L. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDIKRO OY |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEHOW INNOVATIVE LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MIR MEDICAL INTERNATIONAL RESEARCH USA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MIR MEDICAL INTL. RESEARCH SRL |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MONITORED THERAPEUTICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MORGAN SCIENTIFIC, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NATIONAL BIOMEDICAL LLC DBA QRS DIAGNOSTIC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NDD MEDIZINTECHNIK AG |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NDD MEDIZITECHNIK AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NUVOAIR AB |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PMD HEALTHCARE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PULMONARY FILTRATION TECHNOLOGIES LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PULMONE ADVANCED MEDICAL DEVICES, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PULMONX CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PULMONX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ROUNDWORKS TECHNOLOGIES PRIVATE LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SAFEY MEDICAL DEVICES PVT LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SDI DIAGNOSTICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
VIASYS RESPIRATORY CARE INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VITALOGRAPH (IRELAND) LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VITALOGRAPH IRELAND LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
VITALOGRAPH(IRELAND) LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
WELCH ALLYN, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
|
|
|
|