510(k) K802644— EMERG. OXYGEN KIT #65350 & #65399 CASE

Substantially Equivalent

B & F Medical Products, Inc.

Clearance details

Applicant: B & F Medical Products, Inc.
Product code: Code CAN
Advisory panel: Anesthesiology
Date received: 1980-10-24
Decision date: 1980-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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.