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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 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 2023-06-14 under 510(k) 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. The listed applicant is Draegerwerk AG & CO Kgaa. The 510(k) number is K222822.

When did VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608) receive FDA 510(k) clearance?

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

Who is the listed applicant for VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)?

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 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 records listing Draegerwerk AG & CO Kgaa as applicant

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Related Devices (Code: BZE)

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.

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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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