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 a medical device manufactured by Cimilre Co., Ltd.. It received FDA 510(k) clearance on 2017-03-07 under approval 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. It is manufactured by Cimilre Co., Ltd.. The 510(k) number is K162870.
When was CIMLRE F1 and CIMILRE S3 approved by the FDA?
CIMLRE F1 and CIMILRE S3 received FDA 510(k) clearance on 2017-03-07, under approval number K162870.
What company makes CIMLRE F1 and CIMILRE S3?
CIMLRE F1 and CIMILRE S3 is manufactured by Cimilre Co., Ltd..
What is the FDA product code for CIMLRE F1 and CIMILRE S3?
The FDA product code for CIMLRE F1 and CIMILRE S3 is HGX.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.