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FDA 510(k)

MEDERI THERAPEUTICS RF GENERATOR CONTROL MODULE

K-Number: K103017 · 2011-01-20

ApplicantMederi Therapeutics, Inc.
Decision Date2011-01-20
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEDERI THERAPEUTICS RF GENERATOR CONTROL MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Mederi Therapeutics, Inc.. It received FDA 510(k) clearance on 2011-01-20 under 510(k) number K103017. 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 MEDERI THERAPEUTICS RF GENERATOR CONTROL MODULE?

MEDERI THERAPEUTICS RF GENERATOR CONTROL MODULE is a medical device that received FDA 510(k) clearance on 2011-01-20. The listed applicant is Mederi Therapeutics, Inc.. The 510(k) number is K103017.

When did MEDERI THERAPEUTICS RF GENERATOR CONTROL MODULE receive FDA 510(k) clearance?

MEDERI THERAPEUTICS RF GENERATOR CONTROL MODULE received FDA 510(k) clearance on 2011-01-20, under 510(k) number K103017.

Who is the listed applicant for MEDERI THERAPEUTICS RF GENERATOR CONTROL MODULE?

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

What is the FDA product code for MEDERI THERAPEUTICS RF GENERATOR CONTROL MODULE?

The FDA product code for MEDERI THERAPEUTICS RF GENERATOR CONTROL MODULE 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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