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FDA 510(k)

VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)

K-Number: K242769 · 2025-04-04

ApplicantDraegerwerk AG & CO Kgaa
Decision Date2025-04-04
Product CodeBTL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) is a medical device manufactured by Draegerwerk AG & CO Kgaa. It received FDA 510(k) clearance on 2025-04-04 under approval number K242769. The device is classified under product code BTL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)?

VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) is a medical device that received FDA 510(k) clearance on 2025-04-04. It is manufactured by Draegerwerk AG & CO Kgaa. The 510(k) number is K242769.

When was VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) approved by the FDA?

VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) received FDA 510(k) clearance on 2025-04-04, under approval number K242769.

What company makes VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)?

VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) is manufactured by Draegerwerk AG & CO Kgaa.

What is the FDA product code for VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)?

The FDA product code for VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) is BTL.

Other Devices by Draegerwerk AG & CO Kgaa

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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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