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FDA 510(k)

QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)

K-Number: K241366 · 2024-10-29

ApplicantDehas Medical Systems GmbH
Decision Date2024-10-29
Product CodeCBP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV) is the device name listed in this FDA 510(k) record. The listed applicant is Dehas Medical Systems GmbH. It received FDA 510(k) clearance on 2024-10-29 under 510(k) number K241366. 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 QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)?

QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV) is a medical device that received FDA 510(k) clearance on 2024-10-29. The listed applicant is Dehas Medical Systems GmbH. The 510(k) number is K241366.

When did QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV) receive FDA 510(k) clearance?

QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV) received FDA 510(k) clearance on 2024-10-29, under 510(k) number K241366.

Who is the listed applicant for QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)?

The FDA 510(k) record lists Dehas Medical Systems GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)?

The FDA product code for QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV) is CBP.

Other records listing Dehas Medical Systems GmbH 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.

K221494Quality Mix Blender, Oxymixer

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.

K234053F&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.K152521Seal Rite Non-Rebreathing ValveThe Lifeguard Store, Inc.

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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