Device Classification Name |
chamber, hyperbaric
|
510(k) Number |
K011592 |
Device Name |
OXYGEN TREATMENT HOOD |
Applicant |
AMRON INTERNATIONAL DIVING SUPPLY, INC. |
759 WEST FOURTH AVE. |
escondido,
CA
92025
|
|
Applicant Contact |
norma f ockwig |
Correspondent |
AMRON INTERNATIONAL DIVING SUPPLY, INC. |
759 WEST FOURTH AVE. |
escondido,
CA
92025
|
|
Correspondent Contact |
norma f ockwig |
Regulation Number | 868.5470
|
Classification Product Code |
|
Date Received | 05/24/2001 |
Decision Date | 06/19/2002 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|