GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER— 510(k) K001409

Name: FDA 510(k) clearance K001409
Creator: U.S. Food and Drug Administration
Published: 2000-08-02

Substantially Equivalent

Hyperbaric Technologies, Inc.

FDA 510(k) clearance K001409 for GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER, Substantially Equivalent on 2000-08-02. Applicant: Hyperbaric Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Hyperbaric Technologies, Inc.
Product code: Code CBF
Device class: Class 2
Regulation: 21 CFR 868.5470
Advisory panel: Anesthesiology
Date received: 2000-05-04
Decision date: 2000-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mccordsville, IN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CBF

product code CBF

Death: 6
Total: 6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.