Device Classification Name |
chamber, hyperbaric
|
510(k) Number |
K100268 |
Device Name |
SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER |
Applicant |
SECHRIST INDUSTRIES, INC. |
4225 EAST LA PALMA AVE. |
ANAHEIM,
CA
92807
|
|
Applicant Contact |
VICTOR ARELLANO |
Correspondent |
SECHRIST INDUSTRIES, INC. |
4225 EAST LA PALMA AVE. |
ANAHEIM,
CA
92807
|
|
Correspondent Contact |
VICTOR ARELLANO |
Regulation Number | 868.5470
|
Classification Product Code |
|
Date Received | 01/29/2010 |
Decision Date | 04/26/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|