MULTIPLACE HYPERBARIC SYSTEM, MODEL MMI HYPERBARIC CHAMBER SYSTEM— 510(k) K030418

Substantially Equivalent

Makai Marine Industries, Inc.

FDA 510(k) clearance K030418 for MULTIPLACE HYPERBARIC SYSTEM, MODEL MMI HYPERBARIC CHAMBER SYSTEM, Substantially Equivalent on 2004-01-29. Applicant: Makai Marine Industries, Inc..

Clearance details

Applicant: Makai Marine Industries, Inc.
Product code: Code CBF
Advisory panel: Anesthesiology
Date received: 2003-02-10
Decision date: 2004-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boca Raton, 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.