LIFEGUARD VENT MASK— 510(k) K883383

Substantially Equivalent

Breath of Life, Inc.

FDA 510(k) clearance K883383 for LIFEGUARD VENT MASK, Substantially Equivalent on 1988-11-21. Applicant: Breath of Life, Inc.. Device class: 2.

Clearance details

Applicant: Breath of Life, Inc.
Product code: Code CBP
Device class: Class 2
Regulation: 21 CFR 868.5870
Advisory panel: Anesthesiology
Date received: 1988-08-09
Decision date: 1988-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flushing, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CBP

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.