510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K011592Substantially Equivalent

Oxygen Treatment Hood

Amron International Diving Supply, Inc., Escondido CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011592 is the FDA 510(k) clearance record for OXYGEN TREATMENT HOOD, a class II device, cleared for Amron International Diving Supply, Inc. on under FDA product code CBF (Chamber, Hyperbaric). FDA records list one 510(k) clearance for Amron International Diving Supply, Inc. As of , FDA records show no recalls naming K011592.

Clearance record

Decision date
Received
(391 days to decision)
Product code
CBF Chamber, Hyperbaric
Regulation
21 CFR 868.5470
Device class
Class II
Review panel
Anesthesiology
Applicant
Amron International Diving Supply, Inc. 759 W. Fourth Ave., Escondido CA
510(k) summary
Summary
Third party review
No

Clearances, product code CBF

Trailing 12 months

FDA records hold no clearances under product code CBF in the trailing twelve months.

FDA records show no clearances under product code CBF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CBF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260