Device Classification Name |
chamber, hyperbaric
|
510(k) Number |
K081506 |
Device Name |
HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS |
Applicant |
HYPERBARIC AMERICA, LLC |
1811 COPPER RIDGE DR. |
SAN ANTONIO,
TX
78259
|
|
Applicant Contact |
TOM WORKMAN |
Correspondent |
HYPERBARIC AMERICA, LLC |
1811 COPPER RIDGE DR. |
SAN ANTONIO,
TX
78259
|
|
Correspondent Contact |
TOM WORKMAN |
Regulation Number | 868.5470
|
Classification Product Code |
|
Date Received | 05/29/2008 |
Decision Date | 07/25/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|