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FDA 510(k)

LEVEEN NEEDLE ELECTRODE(TM)

K-Number: K950347 · 1995-02-23

ApplicantRadiotherapeutics Corp.
Decision Date1995-02-23
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LEVEEN NEEDLE ELECTRODE(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Radiotherapeutics Corp.. It received FDA 510(k) clearance on 1995-02-23 under 510(k) number K950347. 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 LEVEEN NEEDLE ELECTRODE(TM)?

LEVEEN NEEDLE ELECTRODE(TM) is a medical device that received FDA 510(k) clearance on 1995-02-23. The listed applicant is Radiotherapeutics Corp.. The 510(k) number is K950347.

When did LEVEEN NEEDLE ELECTRODE(TM) receive FDA 510(k) clearance?

LEVEEN NEEDLE ELECTRODE(TM) received FDA 510(k) clearance on 1995-02-23, under 510(k) number K950347.

Who is the listed applicant for LEVEEN NEEDLE ELECTRODE(TM)?

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 LEVEEN NEEDLE ELECTRODE(TM)?

The FDA product code for LEVEEN NEEDLE ELECTRODE(TM) is GEI.

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Other records listing Radiotherapeutics Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K011220LEVEEN REFLECT MONOPOLAR/BIPOLAR NEEDLE ELECTRODEK012315LEVEEN ELECTRODEK000241RADIOTHERAPEUTICS RF 3000 RADIOFREQUENCY GENERATORK982556LEVEEN NEEDLE ELECTRODEK000032LEVEEN NEEDLE ELECTRODEK982854MR COMPATIBLE LEVEEN NEEDLE ELECTRODE

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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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