510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K860128Substantially Equivalent

Modac-Xxxx Intensive Monitoring of EEG

Grass-Telefactor Product Group, W. Conshohocken PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860128 is the FDA 510(k) clearance record for MODAC-XXXX INTENSIVE MONITORING OF EEG, a class II device, cleared for Grass-Telefactor Product Group on under FDA product code GYE (Encephalogram Telemetry System). FDA records list 12 510(k) clearances for Grass-Telefactor Product Group, from to . As of , FDA records show no recalls naming K860128.

Clearance record

Decision date
Received
(72 days to decision)
Product code
GYE Encephalogram Telemetry System
Regulation
21 CFR 882.1855
Device class
Class II
Review panel
Neurology
Applicant
Grass-Telefactor Product Group Union Hill Bldg., Dehaven St., W. Conshohocken PA
Third party review
No

Clearances, product code GYE

Trailing 12 months

FDA records hold no clearances under product code GYE in the trailing twelve months.

FDA records show no clearances under product code GYE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GYE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260