AMBU SINGLE PATIENT USE PEEP VALVE— 510(k) K923976

Substantially Equivalent

Ambu, Inc.

FDA 510(k) clearance K923976 for AMBU SINGLE PATIENT USE PEEP VALVE, Substantially Equivalent on 1993-01-05. Applicant: Ambu, Inc..

Clearance details

Applicant: Ambu, Inc.
Product code: Code BYE
Advisory panel: Anesthesiology
Date received: 1992-08-07
Decision date: 1993-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Linthicum, MD, 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.