PORTABLE OXYGEN UNIT— 510(k) K853004

Substantially Equivalent

B & F Medical Products, Inc.

FDA 510(k) clearance K853004 for PORTABLE OXYGEN UNIT, Substantially Equivalent on 1985-08-29. Applicant: B & F Medical Products, Inc..

Clearance details

Applicant: B & F Medical Products, Inc.
Product code: Code CAW
Advisory panel: Anesthesiology
Date received: 1985-07-16
Decision date: 1985-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toledo, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAW

product code CAW

Death: 204
Injury: 573
Malfunction: 1,400
Other: 6
Total: 2,183

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.