OXYHEAL 2000 HYPERBARIC CHAMBER SERIES, MODEL OXYHEAL 2000 SERIES— 510(k) K011866

Substantially Equivalent

Hyperbaric Technologies, Inc.

FDA 510(k) clearance K011866 for OXYHEAL 2000 HYPERBARIC CHAMBER SERIES, MODEL OXYHEAL 2000 SERIES, Substantially Equivalent on 2002-06-06. Applicant: Hyperbaric Technologies, Inc..

Clearance details

Applicant: Hyperbaric Technologies, Inc.
Product code: Code CBF
Advisory panel: Anesthesiology
Date received: 2001-06-14
Decision date: 2002-06-06
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: National City, CA, US

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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.