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FDA 510(k)

CIMLRE F1 and CIMILRE S3

K-Number: K162870 · 2017-03-07

ApplicantCimilre Co., Ltd.
Decision Date2017-03-07
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CIMLRE F1 and CIMILRE S3 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 2017-03-07 under 510(k) number K162870. 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 CIMLRE F1 and CIMILRE S3?

CIMLRE F1 and CIMILRE S3 is a medical device that received FDA 510(k) clearance on 2017-03-07. The listed applicant is Cimilre Co., Ltd.. The 510(k) number is K162870.

When did CIMLRE F1 and CIMILRE S3 receive FDA 510(k) clearance?

CIMLRE F1 and CIMILRE S3 received FDA 510(k) clearance on 2017-03-07, under 510(k) number K162870.

Who is the listed applicant for CIMLRE F1 and CIMILRE S3?

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 CIMLRE F1 and CIMILRE S3?

The FDA product code for CIMLRE F1 and CIMILRE S3 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.

K221708CIMILRE Free-T2 Plus

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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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