FDA 510(k)

CORTICAL MAPPING UNIT, MODEL CMU

K-Number: K992194 · 1999-09-13

ApplicantAd-Tech Medical Instrument Corp

Decision Date1999-09-13

Product CodeGYC

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

CORTICAL MAPPING UNIT, MODEL CMU is the device name listed in this FDA 510(k) record. The listed applicant is Ad-Tech Medical Instrument Corp. It received FDA 510(k) clearance on 1999-09-13 under 510(k) number K992194. The device is classified under product code GYC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORTICAL MAPPING UNIT, MODEL CMU?

CORTICAL MAPPING UNIT, MODEL CMU is a medical device that received FDA 510(k) clearance on 1999-09-13. The listed applicant is Ad-Tech Medical Instrument Corp. The 510(k) number is K992194.

When did CORTICAL MAPPING UNIT, MODEL CMU receive FDA 510(k) clearance?

CORTICAL MAPPING UNIT, MODEL CMU received FDA 510(k) clearance on 1999-09-13, under 510(k) number K992194.

Who is the listed applicant for CORTICAL MAPPING UNIT, MODEL CMU?

The FDA 510(k) record lists Ad-Tech Medical Instrument Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CORTICAL MAPPING UNIT, MODEL CMU?

The FDA product code for CORTICAL MAPPING UNIT, MODEL CMU is GYC.

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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.