Device Classification Name |
Chamber, Hyperbaric
|
510(k) Number |
K983648 |
Device Name |
SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEM |
Applicant |
PERRY BAROMEDICAL SERVICES |
7555 GARDEN RD. |
SUITE B |
RIVIERA BEACH,
FL
33404
|
|
Applicant Contact |
WAYNE C MCCULLOGH |
Correspondent |
PERRY BAROMEDICAL SERVICES |
7555 GARDEN RD. |
SUITE B |
RIVIERA BEACH,
FL
33404
|
|
Correspondent Contact |
WAYNE C MCCULLOGH |
Regulation Number | 868.5470
|
Classification Product Code |
|
Date Received | 10/16/1998 |
Decision Date | 02/24/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|