Device Classification Name |
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
|
510(k) Number |
K140370 |
Device Name |
DISPOSABLE PRESSURE MANOMETER |
Applicant |
BESMED HEALTH BUSINESS CORP. |
NO.5, LANE116, WU-KONG 2ND RD |
NEW TAIPEI CITY, WU-KU DISTRICT,
TW
TW
|
|
Applicant Contact |
PAUL DRYDEN |
Correspondent |
BESMED HEALTH BUSINESS CORP. |
NO.5, LANE116, WU-KONG 2ND RD |
NEW TAIPEI CITY, WU-KU DISTRICT,
TW
TW
|
|
Correspondent Contact |
PAUL DRYDEN |
Regulation Number | 868.2600
|
Classification Product Code |
|
Date Received | 02/14/2014 |
Decision Date | 06/19/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|