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

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..

Clearance details

Applicant: Mechidyne Systems, Inc.
Product code: Code CBF
Advisory panel: Anesthesiology
Date received: 2002-07-08
Decision date: 2003-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, 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.