Device Classification Name |
Chamber, Hyperbaric
|
510(k) Number |
K053498 |
Device Name |
HYPEROX 101 |
Applicant |
WJO, INC |
424 MILL STREET AT CANAL'S END |
PLAZA |
BRISTOL,
PA
19007
|
|
Applicant Contact |
CHRIS BELLETIERI |
Correspondent |
WJO, INC |
424 MILL STREET AT CANAL'S END |
PLAZA |
BRISTOL,
PA
19007
|
|
Correspondent Contact |
CHRIS BELLETIERI |
Regulation Number | 868.5470
|
Classification Product Code |
|
Date Received | 12/16/2005 |
Decision Date | 03/15/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|