AMBU CPAP SYSTEM— 510(k) K851194

Substantially Equivalent

Ambu, Inc.

FDA 510(k) clearance K851194 for AMBU CPAP SYSTEM, Substantially Equivalent on 1985-04-15. Applicant: Ambu, Inc..

Clearance details

Applicant: Ambu, Inc.
Product code: Code BYE
Advisory panel: Anesthesiology
Date received: 1985-03-26
Decision date: 1985-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danbury, CT, US

Download summary PDF View on FDA.gov ↗

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.