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FDA 510(k)

CPR SHIELD

K-Number: K942671 · 1995-02-07

ApplicantRondex Products, Inc.
Decision Date1995-02-07
Product CodeCBP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CPR SHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Rondex Products, Inc.. It received FDA 510(k) clearance on 1995-02-07 under 510(k) number K942671. 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 CPR SHIELD?

CPR SHIELD is a medical device that received FDA 510(k) clearance on 1995-02-07. The listed applicant is Rondex Products, Inc.. The 510(k) number is K942671.

When did CPR SHIELD receive FDA 510(k) clearance?

CPR SHIELD received FDA 510(k) clearance on 1995-02-07, under 510(k) number K942671.

Who is the listed applicant for CPR SHIELD?

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

What is the FDA product code for CPR SHIELD?

The FDA product code for CPR SHIELD is CBP.

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Other records listing Rondex Products, 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.

K981169RONDEX CPR ISO-SHIELDK943761NON-BREATHING VALVEK921002RONDEX MASK MODELS 9122/9111/9102/911102, MODIFIEDK914195RONDEX CPR NON REBREATHING VALVE #9030, MODIFIEDK914196RONDEX MASKS MODELS 9015/9011/901102 MODIFIEDK902299CPR VALVE (NON-REBREATHING) MODEL #9030

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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

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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