FDA 510(k)

FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+)

K-Number: K123310 · 2013-01-23

Decision Date2013-01-23

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+) is the device name listed in this FDA 510(k) record. The listed applicant is Utah Medical Products, Inc.. It received FDA 510(k) clearance on 2013-01-23 under 510(k) number K123310. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+)?

FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+) is a medical device that received FDA 510(k) clearance on 2013-01-23. The listed applicant is Utah Medical Products, Inc.. The 510(k) number is K123310.

When did FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+) receive FDA 510(k) clearance?

FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+) received FDA 510(k) clearance on 2013-01-23, under 510(k) number K123310.

Who is the listed applicant for FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+)?

The FDA 510(k) record lists Utah Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+)?

The FDA product code for FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+) is GEI.

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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.