K904920

Substantially Equivalent

AMBU MATIC AUTOMATIC RESUSCITATOR

Applicant: Ambu, Inc.
Product code: BTL
Advisory panel: Anesthesiology
Date received: 1990-10-31
Decision date: 1991-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hanover, MD, US

Adverse events under product code BTL

product code BTL

Death: 8
Malfunction: 3,256
Other: 1
Total: 3,265

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.