| Device Classification Name |
Chamber, Hyperbaric
|
| 510(k) Number |
K930748 |
| Device Name |
SIGMA MP MULTIPLACE HYPERBARIC CHAMBER |
| Applicant |
| Perry Baromedical Services |
| 7555 Garden Rd. |
| Suite B |
|
Riviera Beach,
FL
33404
|
|
| Applicant Contact |
DENNIS J HOLSTEIN |
| Correspondent |
| Perry Baromedical Services |
| 7555 Garden Rd. |
| Suite B |
|
Riviera Beach,
FL
33404
|
|
| Correspondent Contact |
DENNIS J HOLSTEIN |
| Regulation Number | 868.5470 |
| Classification Product Code |
|
| Date Received | 02/12/1993 |
| Decision Date | 08/20/1993 |
| 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
|
|
|