Device Classification Name |
Generator, Oxygen, Portable
|
510(k) Number |
K091716 |
Device Name |
MERITS HEALTH PRODUCTS PROFIL Q601 SERIES OXYGEN FILLING ACCESSORY |
Applicant |
MERITS HEALTH PRODUCTS CO., LTD. |
9, ROAD 36 |
TAICHUNG INDUSTRIAL PARK |
TAICHUNG,
TW
407
|
|
Applicant Contact |
STEVE CHAO |
Correspondent |
MERITS HEALTH PRODUCTS CO., LTD. |
9, ROAD 36 |
TAICHUNG INDUSTRIAL PARK |
TAICHUNG,
TW
407
|
|
Correspondent Contact |
STEVE CHAO |
Regulation Number | 868.5440
|
Classification Product Code |
|
Date Received | 06/10/2009 |
Decision Date | 04/02/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|