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FDA 510(k)

Evita V800, Evita V600

K-Number: K222024 · 2023-05-16

ApplicantDraegerwerk AG & CO Kgaa
Decision Date2023-05-16
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Evita V800, Evita V600 is the device name listed in this FDA 510(k) record. The listed applicant is Draegerwerk AG & CO Kgaa. It received FDA 510(k) clearance on 2023-05-16 under 510(k) number K222024. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Evita V800, Evita V600?

Evita V800, Evita V600 is a medical device that received FDA 510(k) clearance on 2023-05-16. The listed applicant is Draegerwerk AG & CO Kgaa. The 510(k) number is K222024.

When did Evita V800, Evita V600 receive FDA 510(k) clearance?

Evita V800, Evita V600 received FDA 510(k) clearance on 2023-05-16, under 510(k) number K222024.

Who is the listed applicant for Evita V800, Evita V600?

The FDA 510(k) record lists Draegerwerk AG & CO Kgaa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Evita V800, Evita V600?

The FDA product code for Evita V800, Evita V600 is CBK.

Other records listing Draegerwerk AG & CO Kgaa as applicant

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K253647Evita (V800); Evita (V600)K242769VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)K222822VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)K222207Babylog VN800, Babylog VN600K221118CO2 Mainstream SensorK162821Babyleo TN500

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Related Devices (Code: CBK)

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.

K253647Evita (V800); Evita (V600)Draegerwerk AG & CO KgaaK252663Inbentus VersatileIconic Solutions by Murcia, SLK251888VPAP Pediatric Face MaskHsiner Co., Ltd.K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.K252173F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented FullFisher & Paykel Healthcare, Ltd.K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics 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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