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

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..

Clearance details

Applicant: Hyox Systems C/O Mechidyne Systems, Inc.
Product code: Code CBF
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 ↗

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.