Device Classification Name |
gas-machine, anesthesia
|
510(k) Number |
K151954 |
Device Name |
A7 Anesthesia System |
Applicant |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. |
MINDRAY BUILDING, KEJI 12TH ROAD SOUTH, HI-TECH INDUSTRIAL |
PARK, NANSHAN |
SHENZHEN,
CN
518057
|
|
Applicant Contact |
TANG HAO |
Correspondent |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. |
MINDRAY BUILDING, KEJI 12TH ROAD SOUTH, HI-TECH INDUSTRIAL |
PARK, NANSHAN |
SHENZHEN,
CN
518057
|
|
Correspondent Contact |
TANG HAO |
Regulation Number | 868.5160
|
Classification Product Code |
|
Date Received | 07/15/2015 |
Decision Date | 10/27/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|