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 |