510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864660Substantially Equivalent

Model M402 EMG Monitor

Bio-Logic Devices, Deer Park NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864660 is the FDA 510(k) clearance record for MODEL M402 EMG MONITOR, a class II device, cleared for Bio-Logic Devices on under FDA product code IKN (Electromyograph, Diagnostic). FDA records list 4 510(k) clearances for Bio-Logic Devices, from to . As of , FDA records show no recalls naming K864660.

Clearance record

Decision date
Received
(68 days to decision)
Product code
IKN Electromyograph, Diagnostic
Regulation
21 CFR 890.1375
Device class
Class II
Review panel
Physical Medicine
Applicant
Bio-Logic Devices 62m S. Second St., Deer Park NY
Third party review
No

Clearances, product code IKN

Trailing 12 months

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

FDA records show no clearances under product code IKN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IKN, 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