Device Classification Name |
Generator, Oxygen, Portable
|
510(k) Number |
K102245 |
Device Name |
CARE ZY5BA OXYGEN CONCENTRATOR |
Applicant |
FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD. |
KEJIMAN 12 ROAD, HI-TEC IND PK |
HUATONGWEI BLDG |
NANSHAN, SHENZHEN,
CN
518057
|
|
Applicant Contact |
KATHY GUO |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
2600 NW LAKE RD. |
CAMAS,
WA
98607 -9526
|
|
Correspondent Contact |
MARC M MOUSER |
Regulation Number | 868.5440
|
Classification Product Code |
|
Date Received | 08/09/2010 |
Decision Date | 11/09/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|