| Device Classification Name |
Ventilator, Continuous, Facility Use
|
| 510(k) Number |
K964540 |
| Device Name |
NELLCOR PURITAN BENNETT, 740 VENTILATOR SYSTEM |
| Applicant |
| Puritan Bennett Corp. |
| 2200 Faraday Ave. |
|
Carlsbad,
CA
92008
|
|
| Applicant Contact |
ANN-MARIE BUTLER |
| Correspondent |
| Puritan Bennett Corp. |
| 2200 Faraday Ave. |
|
Carlsbad,
CA
92008
|
|
| Correspondent Contact |
ANN-MARIE BUTLER |
| Regulation Number | 868.5895 |
| Classification Product Code |
|
| Date Received | 11/12/1996 |
| Decision Date | 11/14/1997 |
| Decision |
SE SUBJECT TO TRACKING REG
(ST) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
| Recalls |
CDRH Recalls
|
|
|