| 510(k) Number |
K864430 |
| Device Name |
MA-2 AND MA2+2 VOLUME VENTILATORS |
| Applicant |
| Puritan Bennett Corp. |
| 9401 Indian Creek Pkwy. |
| P.O. Box 25905 |
|
Overland Park,
KS
66225
|
|
| Applicant Contact |
HARTLEY C ERICSON |
| Correspondent |
| Puritan Bennett Corp. |
| 9401 Indian Creek Pkwy. |
| P.O. Box 25905 |
|
Overland Park,
KS
66225
|
|
| Correspondent Contact |
HARTLEY C ERICSON |
| Date Received | 11/12/1986 |
| Decision Date | 01/15/1987 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Anesthesiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|