H.T.U. (HYPERBARIC THERAPY UNIT)— 510(k) K874107

Name: FDA 510(k) clearance K874107
Creator: U.S. Food and Drug Administration
Published: 1987-12-07

Substantially Equivalent

Hyox Systems C/O Mechidyne Systems, Inc.

FDA 510(k) clearance K874107 for H.T.U. (HYPERBARIC THERAPY UNIT), Substantially Equivalent on 1987-12-07. Applicant: Hyox Systems C/O Mechidyne Systems, Inc.. Device class: 2.

Clearance details

Applicant: Hyox Systems C/O Mechidyne Systems, Inc.
Product code: Code CBF
Device class: Class 2
Regulation: 21 CFR 868.5470
Advisory panel: Anesthesiology
Date received: 1987-10-09
Decision date: 1987-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, 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
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.