|
Device |
meter, peak flow, spirometry |
Product Code | BZH |
Regulation Number |
868.1860
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
BEIJING M&B ELECTRONIC INSTRUMENTS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BEIJING M&B ELECTRONIC INSTRUMENTS, CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BESMED HEALTH BUSINESS CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BREATHE ME LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DYNAMITECH MEDICAL, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GOSTAR CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GUANGZHOU HOMESUN MEDICAL TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
K-JUMP HEALTH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KNOX MEDICAL DIAGNOSTICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MIR MEDICAL INTERNATIONAL RESEARCH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MONAGHAN MEDICAL CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NOBLE MARKETING |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SAFEY MEDICAL DEVICES PVT LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANGHAI SONMOL MEDICAL EQUIPMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPARO INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TAIAN DALU MEDICAL INSTRUMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VIASYS HEALTHCARE GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
MDR Year |
MDR Reports |
MDR Events |
2014 |
22 |
22 |
2015 |
1 |
1 |
|
|
|
|