The following data is part of a premarket notification filed by Amron International Diving Supply, Inc. with the FDA for Oxygen Treatment Hood.
| Device ID | K011592 |
| 510k Number | K011592 |
| Device Name: | OXYGEN TREATMENT HOOD |
| Classification | Chamber, Hyperbaric |
| Applicant | AMRON INTERNATIONAL DIVING SUPPLY, INC. 759 WEST FOURTH AVE. Escondido, CA 92025 |
| Contact | Norma F Ockwig |
| Correspondent | Norma F Ockwig AMRON INTERNATIONAL DIVING SUPPLY, INC. 759 WEST FOURTH AVE. Escondido, CA 92025 |
| Product Code | CBF |
| CFR Regulation Number | 868.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-24 |
| Decision Date | 2002-06-19 |
| Summary: | summary |