OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER— 510(k) K052866

Substantially Equivalent

Oxyheal Health Group

FDA 510(k) clearance K052866 for OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER, Substantially Equivalent on 2005-12-13. Applicant: Oxyheal Health Group.

Clearance details

Applicant: Oxyheal Health Group
Product code: Code CBF
Advisory panel: Anesthesiology
Date received: 2005-10-11
Decision date: 2005-12-13
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.