NON REBREATHING VALVE— 510(k) K913163

Name: FDA 510(k) clearance K913163
Creator: U.S. Food and Drug Administration
Published: 1992-02-03

Substantially Equivalent

Specialty Packaging Producs, Inc.

FDA 510(k) clearance K913163 for NON REBREATHING VALVE, Substantially Equivalent on 1992-02-03. Applicant: Specialty Packaging Producs, Inc.. Device class: 2.

Clearance details

Applicant: Specialty Packaging Producs, Inc.
Product code: Code CBP
Device class: Class 2
Regulation: 21 CFR 868.5870
Advisory panel: Anesthesiology
Date received: 1991-07-17
Decision date: 1992-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: El Paso, TX, 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

More clearances from Specialty Packaging Producs, Inc.

view all

K922492 — SPECIALTY PACKAGING PROD BACTERIAL/VIRAL FILTER1992-08-24
K913422 — OXYGEN TUBING, 815031992-01-30
K913164 — NON REBREATHING MASK1992-01-15
K913216 — TRACH T ADAPTER1992-01-15
K913383 — OXYGEN MASKS 81420, 81421, 81471 & 814611991-10-18

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