FDA 510(k)

CIMILRE Free-T2 Plus

K-Number: K221708 · 2022-12-23

Decision Date2022-12-23

Product CodeHGX

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

CIMILRE Free-T2 Plus is a medical device manufactured by Cimilre Co., Ltd.. It received FDA 510(k) clearance on 2022-12-23 under approval number K221708. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CIMILRE Free-T2 Plus?

CIMILRE Free-T2 Plus is a medical device that received FDA 510(k) clearance on 2022-12-23. It is manufactured by Cimilre Co., Ltd.. The 510(k) number is K221708.

When was CIMILRE Free-T2 Plus approved by the FDA?

CIMILRE Free-T2 Plus received FDA 510(k) clearance on 2022-12-23, under approval number K221708.

What company makes CIMILRE Free-T2 Plus?

CIMILRE Free-T2 Plus is manufactured by Cimilre Co., Ltd..

What is the FDA product code for CIMILRE Free-T2 Plus?

The FDA product code for CIMILRE Free-T2 Plus is HGX.

Other Devices by Cimilre Co., Ltd.

K162870CIMLRE F1 and CIMILRE S3

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.