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FDA 510(k)

Thermi RF Accessories

K-Number: K161661 · 2016-08-12

ApplicantThermi
Decision Date2016-08-12
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Thermi RF Accessories is a medical device manufactured by Thermi. It received FDA 510(k) clearance on 2016-08-12 under approval number K161661. 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 Thermi RF Accessories?

Thermi RF Accessories is a medical device that received FDA 510(k) clearance on 2016-08-12. It is manufactured by Thermi. The 510(k) number is K161661.

When was Thermi RF Accessories approved by the FDA?

Thermi RF Accessories received FDA 510(k) clearance on 2016-08-12, under approval number K161661.

What company makes Thermi RF Accessories?

Thermi RF Accessories is manufactured by Thermi.

What is the FDA product code for Thermi RF Accessories?

The FDA product code for Thermi RF Accessories 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.

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