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FDA 510(k)

FreeStyle Comfort (AS200 / FreeStyle Comfort)

K-Number: K250671 · 2025-07-11

ApplicantCaire, Inc.
Decision Date2025-07-11
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FreeStyle Comfort (AS200 / FreeStyle Comfort) is a medical device manufactured by Caire, Inc.. It received FDA 510(k) clearance on 2025-07-11 under approval number K250671. The device is classified under product code CAW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FreeStyle Comfort (AS200 / FreeStyle Comfort)?

FreeStyle Comfort (AS200 / FreeStyle Comfort) is a medical device that received FDA 510(k) clearance on 2025-07-11. It is manufactured by Caire, Inc.. The 510(k) number is K250671.

When was FreeStyle Comfort (AS200 / FreeStyle Comfort) approved by the FDA?

FreeStyle Comfort (AS200 / FreeStyle Comfort) received FDA 510(k) clearance on 2025-07-11, under approval number K250671.

What company makes FreeStyle Comfort (AS200 / FreeStyle Comfort)?

FreeStyle Comfort (AS200 / FreeStyle Comfort) is manufactured by Caire, Inc..

What is the FDA product code for FreeStyle Comfort (AS200 / FreeStyle Comfort)?

The FDA product code for FreeStyle Comfort (AS200 / FreeStyle Comfort) is CAW.

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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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