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FDA 510(k)

CIMILRE Free-T2 Plus

K-Number: K221708 · 2022-12-23

ApplicantCimilre Co., Ltd.
Decision Date2022-12-23
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CIMILRE Free-T2 Plus is the device name listed in this FDA 510(k) record. The listed applicant is Cimilre Co., Ltd.. It received FDA 510(k) clearance on 2022-12-23 under 510(k) 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. The listed applicant is Cimilre Co., Ltd.. The 510(k) number is K221708.

When did CIMILRE Free-T2 Plus receive FDA 510(k) clearance?

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

Who is the listed applicant for CIMILRE Free-T2 Plus?

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

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

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

Other records listing Cimilre Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K162870CIMLRE F1 and CIMILRE S3

Related Devices (Code: HGX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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