Device Classification Name |
Attachment, Breathing, Positive End Expiratory Pressure
|
510(k) Number |
K160112 |
Device Name |
Besmed PEEP Valve |
Applicant |
BESMED HEALTH BUSINESS CORP. |
NO.5, LANE 116, WU-KONG 2ND RD |
NEW TAIPEI CITY,
TW
|
|
Applicant Contact |
ERIC LI |
Correspondent |
BESMED HEALTH BUSINESS CORP. |
NO.5, LANE 116, WU-KONG 2ND RD |
NEW TAIPEI CITY,
TW
|
|
Correspondent Contact |
PAUL DRYDEN |
Regulation Number | 868.5965
|
Classification Product Code |
|
Date Received | 01/19/2016 |
Decision Date | 04/29/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|