| Device Classification Name |
Ventilator, Continuous, Facility Use
|
| 510(k) Number |
K895513 |
| Device Name |
PERRY SV-1 HYPERBARIC VENTILATOR |
| Applicant |
| Perry Baromedical Services |
| 7555 Garden Rd. |
| Suite B |
|
Riviera Beach,
FL
33404
|
|
| Applicant Contact |
DONALD W GRISSETT |
| Correspondent |
| Perry Baromedical Services |
| 7555 Garden Rd. |
| Suite B |
|
Riviera Beach,
FL
33404
|
|
| Correspondent Contact |
DONALD W GRISSETT |
| Regulation Number | 868.5895 |
| Classification Product Code |
|
| Date Received | 09/12/1989 |
| Decision Date | 12/19/1990 |
| 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
|
|
|