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FDA 510(k)

FreeStyle Comfort (AS200 / FreeStyle Comfort)

N.º K: K250671 · 2025-07-11

SolicitanteCaire, Inc.
Fecha de decisión2025-07-11
Código de productoCAW
Comité asesorAN
DecisiónSubstantially Equivalent

Resumen del dispositivo

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

Preguntas frecuentes

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. The listed applicant is Caire, Inc.. The 510(k) number is K250671.

When did FreeStyle Comfort (AS200 / FreeStyle Comfort) receive FDA 510(k) clearance?

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

Who is the listed applicant for FreeStyle Comfort (AS200 / FreeStyle Comfort)?

The FDA 510(k) record lists Caire, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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Fuente oficial

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