HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS— 510(k) K081506

Name: FDA 510(k) clearance K081506
Creator: U.S. Food and Drug Administration
Published: 2008-07-25

Substantially Equivalent

Hyperbaric America, LLC

FDA 510(k) clearance K081506 for HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS, Substantially Equivalent on 2008-07-25. Applicant: Hyperbaric America, LLC. Device class: 2.

Clearance details

Applicant: Hyperbaric America, LLC
Product code: Code CBF
Device class: Class 2
Regulation: 21 CFR 868.5470
Advisory panel: Anesthesiology
Date received: 2008-05-29
Decision date: 2008-07-25
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

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K220290 — Revitalair 430+2023-05-04
K171899 — Revitalair 430F2019-11-22
K163109 — OxyHeal 4000 Multiplace Hyperbaric Chamber Family2017-03-22
K152223 — Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System2016-04-29

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.