Device Classification Name |
valve, non-rebreathing
|
510(k) Number |
K142764 |
Device Name |
KYOLING CPR Mask with Oxygen Port and Without Oxygen Port |
Applicant |
HANGZHOU JINLIN MEDICAL APPLIANCES CO., LTD. |
No. 9 16TH AVE HANGZHOU ECONOMIC & |
TECHNOLOGICAL DEVELOPMENT ZONE |
HANGZHOU,
CN
310018
|
|
Applicant Contact |
Lydia HE |
Correspondent |
OSMUNDA MEDICAL DEVICE CONSULTING CO., LTD. |
7th Floor Jingui Business Buildng No. 982 Cogyuan Rd |
BAIYUN DISTRICT |
GUANGZHOU,
CN
510420
|
|
Correspondent Contact |
Mike Gu |
Regulation Number | 868.5870
|
Classification Product Code |
|
Date Received | 09/25/2014 |
Decision Date | 07/09/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|