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FDA 510(k)

NON-BREATHING VALVE

K-Number: K943761 · 1994-11-10

ApplicantRondex Products, Inc.
Decision Date1994-11-10
Product CodeCBP
Advisory CommitteeAN
DecisionUnknown

Device Summary

NON-BREATHING VALVE 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 1994-11-10 under 510(k) number K943761. The device is classified under product code CBP. It was reviewed by the AN advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the NON-BREATHING VALVE?

NON-BREATHING VALVE is a medical device that received FDA 510(k) clearance on 1994-11-10. The listed applicant is Rondex Products, Inc.. The 510(k) number is K943761.

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

NON-BREATHING VALVE received FDA 510(k) clearance on 1994-11-10, under 510(k) number K943761.

Who is the listed applicant for NON-BREATHING VALVE?

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 NON-BREATHING VALVE?

The FDA product code for NON-BREATHING VALVE 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-SHIELDK942671CPR SHIELDK921002RONDEX 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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