HYPERBARIC OXYGEN CHAMBER— 510(k) K790693

Substantially Equivalent

Hyperbaric Oxygen Therapy, Inc.

FDA 510(k) clearance K790693 for HYPERBARIC OXYGEN CHAMBER, Substantially Equivalent on 1979-07-30. Applicant: Hyperbaric Oxygen Therapy, Inc..

Clearance details

Applicant: Hyperbaric Oxygen Therapy, Inc.
Product code: Code CBF
Advisory panel: Anesthesiology
Date received: 1979-04-10
Decision date: 1979-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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.