FDA 510(k) Search

K Number

K250671

Device Name

FreeStyle Comfort (AS200 / FreeStyle Comfort)

Manufacturer

CAIRE Inc.

Date Cleared

2025-07-11

Product Code

CAW

Regulation Number

868.5440

Intended Use

PDF not available yet

Device Description

PDF not available yet

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

AI/ML (Artificial Intelligence / Machine Learning)

null

Therapeutic

null

Diagnostic

null

SaMD (Software as a Medical Device)

null

IVD (In Vitro Diagnostic)

null

PCCP (Predetermined Change Control Plan) Authorized

null

Overview

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Summary

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