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

Name: FDA 510(k) clearance K802644
Creator: U.S. Food and Drug Administration
Published: 1980-12-22

Substantially Equivalent

B & F Medical Products, Inc.

FDA 510(k) clearance K802644 for EMERG. OXYGEN KIT #65350 & #65399 CASE, Substantially Equivalent on 1980-12-22. Applicant: B & F Medical Products, Inc.. Device class: 1.

Clearance details

Applicant: B & F Medical Products, Inc.
Product code: Code CAN
Device class: Class 1
Regulation: 21 CFR 868.2700
Advisory panel: Anesthesiology
Date received: 1980-10-24
Decision date: 1980-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K913501 — TRACHEOSTOMY MASK1992-01-13
K861325 — MAXI-USE O2 DEVICE1986-09-09
K861054 — DISPOSABLE RESCUE BREATHING DEVICE1986-04-09

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.