RESCUER— 510(k) K822727

Substantially Equivalent

Armstrong Ind., Inc.

FDA 510(k) clearance K822727 for RESCUER, Substantially Equivalent on 1982-09-28. Applicant: Armstrong Ind., Inc..

Clearance details

Applicant: Armstrong Ind., Inc.
Product code: Code CAE
Advisory panel: Anesthesiology
Date received: 1982-09-08
Decision date: 1982-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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.