Device Classification Name |
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
|
510(k) Number |
K003497 |
Device Name |
DISPOSABLE PRESSURE MONITOR |
Applicant |
ENGINEERED MEDICAL SYSTEMS |
6329 W. WATERVIEW CT. |
MCCORDSVILLE,
IN
46055
|
|
Applicant Contact |
PAUL DRYDEN |
Correspondent |
ENGINEERED MEDICAL SYSTEMS |
6329 W. WATERVIEW CT. |
MCCORDSVILLE,
IN
46055
|
|
Correspondent Contact |
PAUL DRYDEN |
Regulation Number | 868.2600
|
Classification Product Code |
|
Date Received | 11/13/2000 |
Decision Date | 11/30/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|