OXY-VAC— 510(k) K842205

Substantially Equivalent

Medi-Tech, Inc.

FDA 510(k) clearance K842205 for OXY-VAC, Substantially Equivalent on 1984-06-25. Applicant: Medi-Tech, Inc..

Clearance details

Applicant: Medi-Tech, Inc.
Product code: Code BSY
Advisory panel: Anesthesiology
Date received: 1984-06-04
Decision date: 1984-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code BSY

product code BSY

Death: 3
Injury: 155
Malfunction: 959
Total: 1,117

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.