Device Classification Name |
chamber, hyperbaric
|
510(k) Number |
K011866 |
Device Name |
OXYHEAL 2000 HYPERBARIC CHAMBER SERIES, MODEL OXYHEAL 2000 SERIES |
Applicant |
HYPERBARIC TECHNOLOGIES, INC. |
3224 HOOVER AVE. |
NATIONAL CITY,
CA
91950
|
|
Applicant Contact |
DAVE HEANEY |
Correspondent |
HYPERBARIC TECHNOLOGIES, INC. |
3224 HOOVER AVE. |
NATIONAL CITY,
CA
91950
|
|
Correspondent Contact |
DAVE HEANEY |
Regulation Number | 868.5470
|
Classification Product Code |
|
Date Received | 06/14/2001 |
Decision Date | 06/06/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|