OXYGEN TREATMENT HOOD

Chamber, Hyperbaric

AMRON INTERNATIONAL DIVING SUPPLY, INC.

The following data is part of a premarket notification filed by Amron International Diving Supply, Inc. with the FDA for Oxygen Treatment Hood.

Pre-market Notification Details

Device IDK011592
510k NumberK011592
Device Name:OXYGEN TREATMENT HOOD
ClassificationChamber, Hyperbaric
Applicant AMRON INTERNATIONAL DIVING SUPPLY, INC. 759 WEST FOURTH AVE. Escondido,  CA  92025
ContactNorma F Ockwig
CorrespondentNorma F Ockwig
AMRON INTERNATIONAL DIVING SUPPLY, INC. 759 WEST FOURTH AVE. Escondido,  CA  92025
Product CodeCBF  
CFR Regulation Number868.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-05-24
Decision Date2002-06-19
Summary:summary

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