FDA 510(k)

RADIOTHERAPEUTICS RF GENERATOR. MODEL #RF-2000

K-Number: K972441 · 1997-09-04

Decision Date1997-09-04

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

RADIOTHERAPEUTICS RF GENERATOR. MODEL #RF-2000 is the device name listed in this FDA 510(k) record. The listed applicant is Radiotherapeutics Corp.. It received FDA 510(k) clearance on 1997-09-04 under 510(k) number K972441. 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 RADIOTHERAPEUTICS RF GENERATOR. MODEL #RF-2000?

RADIOTHERAPEUTICS RF GENERATOR. MODEL #RF-2000 is a medical device that received FDA 510(k) clearance on 1997-09-04. The listed applicant is Radiotherapeutics Corp.. The 510(k) number is K972441.

When did RADIOTHERAPEUTICS RF GENERATOR. MODEL #RF-2000 receive FDA 510(k) clearance?

RADIOTHERAPEUTICS RF GENERATOR. MODEL #RF-2000 received FDA 510(k) clearance on 1997-09-04, under 510(k) number K972441.

Who is the listed applicant for RADIOTHERAPEUTICS RF GENERATOR. MODEL #RF-2000?

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

What is the FDA product code for RADIOTHERAPEUTICS RF GENERATOR. MODEL #RF-2000?

The FDA product code for RADIOTHERAPEUTICS RF GENERATOR. MODEL #RF-2000 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.