510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
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K991077Substantially Equivalent

Microelectroencephalography Professional System 5000 (EEG Pro System 5000)

Microrecording Systems Consultants, LLC, Pasadena CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991077 is the FDA 510(k) clearance record for MICROELECTROENCEPHALOGRAPHY PROFESSIONAL SYSTEM 5000 (EEG PRO SYSTEM 5000), a class II device, cleared for Microrecording Systems Consultants, LLC on under FDA product code GZL (Electrode, Depth). FDA records list one 510(k) clearance for Microrecording Systems Consultants, LLC. As of , FDA records show no recalls naming K991077.

Clearance record

Decision date
Received
(70 days to decision)
Product code
GZL Electrode, Depth
Regulation
21 CFR 882.1330
Device class
Class II
Review panel
Neurology
Applicant
Microrecording Systems Consultants, LLC 2842 E. Foothill Blvd., Pasadena CA
510(k) summary
Statement
Third party review
No

Clearances, product code GZL

Trailing 12 months
2 clearances under product code GZL in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GZL, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260