AMBU OXYGEN REGULATOR— 510(k) K921125

Substantially Equivalent

Amg, LLC

FDA 510(k) clearance K921125 for AMBU OXYGEN REGULATOR, Substantially Equivalent on 1992-09-17. Applicant: Amg, LLC.

Clearance details

Applicant: Amg, LLC
Product code: Code CAN
Advisory panel: Anesthesiology
Date received: 1992-03-10
Decision date: 1992-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAN

product code CAN

Death: 4
Other: 1
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.