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FDA 510(k)

RONDEX CPR VALVE

K-Number: K855218 · 1986-02-12

ApplicantKondex Products, Inc.
Decision Date1986-02-12
Product CodeCBP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RONDEX CPR VALVE is the device name listed in this FDA 510(k) record. The listed applicant is Kondex Products, Inc.. It received FDA 510(k) clearance on 1986-02-12 under 510(k) number K855218. 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 RONDEX CPR VALVE?

RONDEX CPR VALVE is a medical device that received FDA 510(k) clearance on 1986-02-12. The listed applicant is Kondex Products, Inc.. The 510(k) number is K855218.

When did RONDEX CPR VALVE receive FDA 510(k) clearance?

RONDEX CPR VALVE received FDA 510(k) clearance on 1986-02-12, under 510(k) number K855218.

Who is the listed applicant for RONDEX CPR VALVE?

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

What is the FDA product code for RONDEX CPR VALVE?

The FDA product code for RONDEX CPR VALVE is CBP.

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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

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

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