| Device Classification Name |
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
|
| 510(k) Number |
K812140 |
| Device Name |
BIRD MEAN AIRWAY PRESSURE MONITOR |
| Applicant |
| 3M Company |
| 2724 S. Peck Rd. |
|
Monrovia,
CA
91016
|
|
| Correspondent |
| 3M Company |
| 2724 S. Peck Rd. |
|
Monrovia,
CA
91016
|
|
| Regulation Number | 868.2600 |
| Classification Product Code |
|
| Date Received | 07/28/1981 |
| Decision Date | 08/20/1981 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|