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FDA 510(k)

COOL-TIP RF SYSTEM

K-Number: K984552 · 1999-03-05

ApplicantRadionics, Inc.
Decision Date1999-03-05
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COOL-TIP RF SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Radionics, Inc.. It received FDA 510(k) clearance on 1999-03-05 under 510(k) number K984552. 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 COOL-TIP RF SYSTEM?

COOL-TIP RF SYSTEM is a medical device that received FDA 510(k) clearance on 1999-03-05. The listed applicant is Radionics, Inc.. The 510(k) number is K984552.

When did COOL-TIP RF SYSTEM receive FDA 510(k) clearance?

COOL-TIP RF SYSTEM received FDA 510(k) clearance on 1999-03-05, under 510(k) number K984552.

Who is the listed applicant for COOL-TIP RF SYSTEM?

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

What is the FDA product code for COOL-TIP RF SYSTEM?

The FDA product code for COOL-TIP RF SYSTEM is GEI.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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