OxyHeal 4000 Multiplace Hyperbaric Chamber Family— 510(k) K163109

Name: FDA 510(k) clearance K163109
Creator: U.S. Food and Drug Administration
Published: 2017-03-22

Substantially Equivalent

Oxyheal Medical Systems, Inc.

FDA 510(k) clearance K163109 for OxyHeal 4000 Multiplace Hyperbaric Chamber Family, Substantially Equivalent on 2017-03-22. Applicant: Oxyheal Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Oxyheal Medical Systems, Inc.
Product code: Code CBF
Device class: Class 2
Regulation: 21 CFR 868.5470
Advisory panel: Anesthesiology
Date received: 2016-11-07
Decision date: 2017-03-22
Decision: Substantially Equivalent
Clearance type: Special
Location: National City, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CBF

view all

K240569 — FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber2024-11-21
K220290 — Revitalair 430+2023-05-04
K171899 — Revitalair 430F2019-11-22
K152223 — Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System2016-04-29
K140559 — SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER2014-05-30

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.