| Device Classification Name |
monitor, airway pressure (includes gauge and/or alarm)
|
| 510(K) Number |
K781714 |
| Device Name |
PNEUMOGARD MODEL 1230 |
| Applicant |
| NOVAMETRIX MEDICAL SYSTEMS, INC. |
|
|
|
| Regulation Number | 868.2600
|
| Classification Product Code |
|
| Date Received | 10/06/1978 |
| Decision Date | 11/27/1978 |
| Decision |
substantially equivalent (SE) |
| Classification Advisory Committee |
Anesthesiology
|
| Review Advisory Committee |
Cardiovascular
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
|
|