DISPOSABLE RESCUE BREATHING DEVICE— 510(k) K861054

Substantially Equivalent

B & F Medical Products, Inc.

FDA 510(k) clearance K861054 for DISPOSABLE RESCUE BREATHING DEVICE, Substantially Equivalent on 1986-04-09. Applicant: B & F Medical Products, Inc..

Clearance details

Applicant: B & F Medical Products, Inc.
Product code: Code CAE
Advisory panel: Anesthesiology
Date received: 1986-03-19
Decision date: 1986-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toledo, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAE

product code CAE

Death: 4
Total: 4

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.