MSI I2010 DUAL PLACE HYPERBARIC CHAMBER— 510(k) K022214

Name: FDA 510(k) clearance K022214
Creator: U.S. Food and Drug Administration
Published: 2003-02-26

Substantially Equivalent

Mechidyne Systems, Inc.

FDA 510(k) clearance K022214 for MSI I2010 DUAL PLACE HYPERBARIC CHAMBER, Substantially Equivalent on 2003-02-26. Applicant: Mechidyne Systems, Inc.. Device class: 2.

Clearance details

Applicant: Mechidyne Systems, Inc.
Product code: Code CBF
Device class: Class 2
Regulation: 21 CFR 868.5470
Advisory panel: Anesthesiology
Date received: 2002-07-08
Decision date: 2003-02-26
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.