| Device Classification Name |
Conserver, Oxygen
|
| 510(k) Number |
K884754 |
| Device Name |
VOYAGER/X |
| Applicant |
| Smith-Perry Corp. |
| 275 W. 10th St. |
|
Riviera Beach,
FL
33404
|
|
| Applicant Contact |
DAVID E SMITH |
| Correspondent |
| Smith-Perry Corp. |
| 275 W. 10th St. |
|
Riviera Beach,
FL
33404
|
|
| Correspondent Contact |
DAVID E SMITH |
| Regulation Number | 868.5905 |
| Classification Product Code |
|
| Date Received | 11/14/1988 |
| Decision Date | 01/04/1989 |
| 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
|
|
|