NON-REBREATHING AIRWAY AND MASK(S) KITS— 510(k) K891124

Name: FDA 510(k) clearance K891124
Creator: U.S. Food and Drug Administration
Published: 1989-10-13

Substantially Equivalent

Airway Products, Inc.

FDA 510(k) clearance K891124 for NON-REBREATHING AIRWAY AND MASK(S) KITS, Substantially Equivalent on 1989-10-13. Applicant: Airway Products, Inc.. Device class: 2.

Clearance details

Applicant: Airway Products, Inc.
Product code: Code CBP
Device class: Class 2
Regulation: 21 CFR 868.5870
Advisory panel: Anesthesiology
Date received: 1989-03-03
Decision date: 1989-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Blue Springs, MO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CBP

view all

K241366 — QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)2024-10-29
K234053 — F&P Optiflow Flow Diverter2024-08-09
K210992 — Altech® Exhalation Valve (Single Limb and Dual Limb)2021-12-23
K192285 — CPR Face Shield2020-11-25
K173770 — OJR215 Pressure Relief Manifold2019-04-05

Data sourced from openFDA. This site is unofficial and independent of the FDA.