HYGROBAC,S HYGROBOY AND HYGROBABY— 510(k) K941381

Substantially Equivalent

Mallinckrodt Medical

FDA 510(k) clearance K941381 for HYGROBAC,S HYGROBOY AND HYGROBABY, Substantially Equivalent on 1994-04-15. Applicant: Mallinckrodt Medical.

Clearance details

Applicant: Mallinckrodt Medical
Product code: Code CAH
Advisory panel: Anesthesiology
Date received: 1994-03-22
Decision date: 1994-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Argyle, NY, US

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Adverse events under product code CAH

product code CAH

Death: 7
Total: 7

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.