Device Classification Name |
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
|
510(k) Number |
K102377 |
Device Name |
VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0-20 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0 |
Applicant |
A PLUS MEDICAL |
5431 AVENIDA ENCINAS |
SUITE G |
CARLSBAD,
CA
92008
|
|
Applicant Contact |
THOMAS C LOESCHER |
Correspondent |
A PLUS MEDICAL |
5431 AVENIDA ENCINAS |
SUITE G |
CARLSBAD,
CA
92008
|
|
Correspondent Contact |
THOMAS C LOESCHER |
Regulation Number | 868.2600
|
Classification Product Code |
|
Date Received | 08/20/2010 |
Decision Date | 11/18/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|