ACKRAD PEDIATRIC C.P.A.P. SYSTEM— 510(k) K880161

Substantially Equivalent

Ackrad Laboratories

FDA 510(k) clearance K880161 for ACKRAD PEDIATRIC C.P.A.P. SYSTEM, Substantially Equivalent on 1988-03-04. Applicant: Ackrad Laboratories.

Clearance details

Applicant: Ackrad Laboratories
Product code: Code BYE
Advisory panel: Anesthesiology
Date received: 1988-01-13
Decision date: 1988-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cranford, NJ, US

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Adverse events under product code BYE

product code BYE

Death: 5
Total: 5

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.