| Device Classification Name |
Conserver, Oxygen
|
| 510(k) Number |
K890141 |
| Device Name |
DEVILBISS MODEL 1400D (OXYGEN CONSERVING DEVICE) |
| Applicant |
| Devilbiss Health Care, Inc. |
| 1200 E. Main St. |
| P.O.Box 635 |
|
Somerset,
PA
15501
|
|
| Applicant Contact |
DAVID GAST |
| Correspondent |
| Devilbiss Health Care, Inc. |
| 1200 E. Main St. |
| P.O.Box 635 |
|
Somerset,
PA
15501
|
|
| Correspondent Contact |
DAVID GAST |
| Regulation Number | 868.5905 |
| Classification Product Code |
|
| Date Received | 01/13/1989 |
| Decision Date | 04/06/1989 |
| 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
|
|
|