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FDA 510(k)

SYMPHONY RF GENERATOR

K-Number: K130689 · 2013-11-15

ApplicantThermigen, Inc.
Decision Date2013-11-15
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SYMPHONY RF GENERATOR is the device name listed in this FDA 510(k) record. The listed applicant is Thermigen, Inc.. It received FDA 510(k) clearance on 2013-11-15 under 510(k) number K130689. 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 SYMPHONY RF GENERATOR?

SYMPHONY RF GENERATOR is a medical device that received FDA 510(k) clearance on 2013-11-15. The listed applicant is Thermigen, Inc.. The 510(k) number is K130689.

When did SYMPHONY RF GENERATOR receive FDA 510(k) clearance?

SYMPHONY RF GENERATOR received FDA 510(k) clearance on 2013-11-15, under 510(k) number K130689.

Who is the listed applicant for SYMPHONY RF GENERATOR?

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

What is the FDA product code for SYMPHONY RF GENERATOR?

The FDA product code for SYMPHONY RF GENERATOR 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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