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FDA 510(k)

VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)

K-Number: K222822 · 2023-06-14

ApplicantDraegerwerk AG & CO Kgaa
Decision Date2023-06-14
Product CodeBZE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608) is a medical device manufactured by Draegerwerk AG & CO Kgaa. It received FDA 510(k) clearance on 2023-06-14 under approval number K222822. The device is classified under product code BZE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)?

VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608) is a medical device that received FDA 510(k) clearance on 2023-06-14. It is manufactured by Draegerwerk AG & CO Kgaa. The 510(k) number is K222822.

When was VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608) approved by the FDA?

VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608) received FDA 510(k) clearance on 2023-06-14, under approval number K222822.

What company makes VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)?

VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608) is manufactured by Draegerwerk AG & CO Kgaa.

What is the FDA product code for VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)?

The FDA product code for VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608) is BZE.

Other Devices by Draegerwerk AG & CO Kgaa

K162821Babyleo TN500 K222024Evita V800, Evita V600 K222207Babylog VN800, Babylog VN600 K221118CO2 Mainstream Sensor K242769VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) K253647Evita (V800); Evita (V600)

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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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