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FDA 510(k)

NON REBREATHING VALVE

K-Number: K913163 · 1992-02-03

ApplicantSpecialty Packaging Producs, Inc.
Decision Date1992-02-03
Product CodeCBP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NON REBREATHING VALVE is the device name listed in this FDA 510(k) record. The listed applicant is Specialty Packaging Producs, Inc.. It received FDA 510(k) clearance on 1992-02-03 under 510(k) number K913163. The device is classified under product code CBP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NON REBREATHING VALVE?

NON REBREATHING VALVE is a medical device that received FDA 510(k) clearance on 1992-02-03. The listed applicant is Specialty Packaging Producs, Inc.. The 510(k) number is K913163.

When did NON REBREATHING VALVE receive FDA 510(k) clearance?

NON REBREATHING VALVE received FDA 510(k) clearance on 1992-02-03, under 510(k) number K913163.

Who is the listed applicant for NON REBREATHING VALVE?

The FDA 510(k) record lists Specialty Packaging Producs, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NON REBREATHING VALVE?

The FDA product code for NON REBREATHING VALVE is CBP.

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Other records listing Specialty Packaging Producs, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K922492SPECIALTY PACKAGING PROD BACTERIAL/VIRAL FILTERK913422OXYGEN TUBING, 81503K913216TRACH T ADAPTERK913164NON REBREATHING MASKK913383OXYGEN MASKS 81420, 81421, 81471 & 81461K913421NASAL OXYGEN CANNULA, 81585, 81587 & 81589

View all 11 devices →

Related Devices (Code: CBP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241366QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)Dehas Medical Systems GmbHK234053F&P Optiflow Flow DiverterFisher & Paykel Healthcare, Ltd.K210992Altech® Exhalation Valve (Single Limb and Dual Limb)Meditera Tibbi Malzeme San VE Tic ASK192285CPR Face ShieldFirstar Healthcare Company Limited (Guangzhou)K173770OJR215 Pressure Relief ManifoldFisher & Paykel Healthcare LimitedK171961Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm)Xiamen Compower Medical Tech. Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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