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FDA 510(k)

RESCUE MASK & CPR VALVE FOR MOUTH-TO-MASK TYPE CPR

K-Number: K881931 · 1988-07-21

ApplicantRondex Products, Inc.
Decision Date1988-07-21
Product CodeCBP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESCUE MASK & CPR VALVE FOR MOUTH-TO-MASK TYPE CPR 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 1988-07-21 under 510(k) number K881931. 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 RESCUE MASK & CPR VALVE FOR MOUTH-TO-MASK TYPE CPR?

RESCUE MASK & CPR VALVE FOR MOUTH-TO-MASK TYPE CPR is a medical device that received FDA 510(k) clearance on 1988-07-21. The listed applicant is Rondex Products, Inc.. The 510(k) number is K881931.

When did RESCUE MASK & CPR VALVE FOR MOUTH-TO-MASK TYPE CPR receive FDA 510(k) clearance?

RESCUE MASK & CPR VALVE FOR MOUTH-TO-MASK TYPE CPR received FDA 510(k) clearance on 1988-07-21, under 510(k) number K881931.

Who is the listed applicant for RESCUE MASK & CPR VALVE FOR MOUTH-TO-MASK TYPE CPR?

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 RESCUE MASK & CPR VALVE FOR MOUTH-TO-MASK TYPE CPR?

The FDA product code for RESCUE MASK & CPR VALVE FOR MOUTH-TO-MASK TYPE CPR is CBP.

Related Clinical Trials

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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 SHIELDK943761NON-BREATHING VALVEK921002RONDEX MASK MODELS 9122/9111/9102/911102, MODIFIEDK914196RONDEX MASKS MODELS 9015/9011/901102 MODIFIEDK914195RONDEX CPR NON REBREATHING VALVE #9030, MODIFIED

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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