'HILT-WAY' RESUSCITATOR— 510(k) K880241

Substantially Equivalent

Medifield , Ltd.

FDA 510(k) clearance K880241 for 'HILT-WAY' RESUSCITATOR, Substantially Equivalent on 1988-03-31. Applicant: Medifield , Ltd..

Clearance details

Applicant: Medifield , Ltd.
Product code: Code CAE
Advisory panel: Anesthesiology
Date received: 1988-01-20
Decision date: 1988-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: England, GB

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Adverse events under product code CAE

product code CAE

Death: 4
Total: 4

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.