INFANT OXYGEN TREATMENT HOOD— 510(k) K011565

Substantially Equivalent

Gulf Coast Hyperbarics, Inc.

FDA 510(k) clearance K011565 for INFANT OXYGEN TREATMENT HOOD, Substantially Equivalent on 2001-08-16. Applicant: Gulf Coast Hyperbarics, Inc..

Clearance details

Applicant: Gulf Coast Hyperbarics, Inc.
Product code: Code CBF
Advisory panel: Anesthesiology
Date received: 2001-05-21
Decision date: 2001-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Panama City, FL, 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.