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FDA 510(k)

MR COMPATIBLE LEVEEN NEEDLE ELECTRODE

K-Number: K982854 · 1998-11-10

ApplicantRadiotherapeutics Corp.
Decision Date1998-11-10
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MR COMPATIBLE LEVEEN NEEDLE ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Radiotherapeutics Corp.. It received FDA 510(k) clearance on 1998-11-10 under 510(k) number K982854. 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 MR COMPATIBLE LEVEEN NEEDLE ELECTRODE?

MR COMPATIBLE LEVEEN NEEDLE ELECTRODE is a medical device that received FDA 510(k) clearance on 1998-11-10. The listed applicant is Radiotherapeutics Corp.. The 510(k) number is K982854.

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

MR COMPATIBLE LEVEEN NEEDLE ELECTRODE received FDA 510(k) clearance on 1998-11-10, under 510(k) number K982854.

Who is the listed applicant for MR COMPATIBLE LEVEEN NEEDLE ELECTRODE?

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 MR COMPATIBLE LEVEEN NEEDLE ELECTRODE?

The FDA product code for MR COMPATIBLE LEVEEN NEEDLE ELECTRODE is GEI.

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Other records listing Radiotherapeutics Corp. as applicant

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Related Devices (Code: 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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