Device Classification Name |
Chamber, Hyperbaric
|
510(k) Number |
K082455 |
Device Name |
RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER |
Applicant |
GULF COAST HYPERBARICS, INC. |
1100 WEST 26TH ST. |
LYNN HAVEN,
FL
32444
|
|
Applicant Contact |
JAMES W MCCARTHY |
Correspondent |
GULF COAST HYPERBARICS, INC. |
1100 WEST 26TH ST. |
LYNN HAVEN,
FL
32444
|
|
Correspondent Contact |
JAMES W MCCARTHY |
Regulation Number | 868.5470
|
Classification Product Code |
|
Date Received | 08/26/2008 |
Decision Date | 05/22/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|