510(k) K910040— AMBU SIR 2 (SILICONE RESUSCITATOR), ADULT

Substantially Equivalent

Ambu, Inc.

Clearance details

Applicant: Ambu, Inc.
Product code: Code BTM
Advisory panel: Anesthesiology
Date received: 1991-01-04
Decision date: 1991-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hanover, MD, US

Adverse events under product code BTM

product code BTM

Death: 19
Other: 2
Total: 21

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.