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FDA 510(k)

MICROELECTROENCEPHALOGRAPHY PROFESSIONAL SYSTEM 5000 (EEG PRO SYSTEM 5000)

K-Number: K991077 · 1999-06-09

ApplicantMicrorecording Systems Consultants, LLC
Decision Date1999-06-09
Product CodeGZL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MICROELECTROENCEPHALOGRAPHY PROFESSIONAL SYSTEM 5000 (EEG PRO SYSTEM 5000) is the device name listed in this FDA 510(k) record. The listed applicant is Microrecording Systems Consultants, LLC. It received FDA 510(k) clearance on 1999-06-09 under 510(k) number K991077. The device is classified under product code GZL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROELECTROENCEPHALOGRAPHY PROFESSIONAL SYSTEM 5000 (EEG PRO SYSTEM 5000)?

MICROELECTROENCEPHALOGRAPHY PROFESSIONAL SYSTEM 5000 (EEG PRO SYSTEM 5000) is a medical device that received FDA 510(k) clearance on 1999-06-09. The listed applicant is Microrecording Systems Consultants, LLC. The 510(k) number is K991077.

When did MICROELECTROENCEPHALOGRAPHY PROFESSIONAL SYSTEM 5000 (EEG PRO SYSTEM 5000) receive FDA 510(k) clearance?

MICROELECTROENCEPHALOGRAPHY PROFESSIONAL SYSTEM 5000 (EEG PRO SYSTEM 5000) received FDA 510(k) clearance on 1999-06-09, under 510(k) number K991077.

Who is the listed applicant for MICROELECTROENCEPHALOGRAPHY PROFESSIONAL SYSTEM 5000 (EEG PRO SYSTEM 5000)?

The FDA 510(k) record lists Microrecording Systems Consultants, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICROELECTROENCEPHALOGRAPHY PROFESSIONAL SYSTEM 5000 (EEG PRO SYSTEM 5000)?

The FDA product code for MICROELECTROENCEPHALOGRAPHY PROFESSIONAL SYSTEM 5000 (EEG PRO SYSTEM 5000) is GZL.

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Official Source

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