INFANT PERCUSSOR PA-010— 510(k) K842608

Substantially Equivalent

Alpha Medical Systems

FDA 510(k) clearance K842608 for INFANT PERCUSSOR PA-010, Substantially Equivalent on 1984-07-23. Applicant: Alpha Medical Systems.

Clearance details

Applicant: Alpha Medical Systems
Product code: Code BYI
Advisory panel: Anesthesiology
Date received: 1984-07-05
Decision date: 1984-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BYI

product code BYI

Death: 3
Total: 3

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.