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FDA 510(k)

Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus

K-Number: K221836 · 2022-12-07

ApplicantDrägerwerk AG & Co. KGaA
Decision Date2022-12-07
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus is a medical device manufactured by Drägerwerk AG & Co. KGaA. It received FDA 510(k) clearance on 2022-12-07 under approval number K221836. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus?

Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus is a medical device that received FDA 510(k) clearance on 2022-12-07. It is manufactured by Drägerwerk AG & Co. KGaA. The 510(k) number is K221836.

When was Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus approved by the FDA?

Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus received FDA 510(k) clearance on 2022-12-07, under approval number K221836.

What company makes Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus?

Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus is manufactured by Drägerwerk AG & Co. KGaA.

What is the FDA product code for Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus?

The FDA product code for Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus is CAH.

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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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