510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K242306Substantially Equivalent

SignalNED System (Model RE)

Forest Devices, Inc., Pittsburgh PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K242306 is the FDA 510(k) clearance record for SignalNED System (Model RE), a class II device, cleared for Forest Devices, Inc. on under FDA product code OMC (Reduced- Montage Standard Electroencephalograph). FDA's definition for product code OMC reads: "Acquire, display, store, and archive electroencephalographic signals from the brain using a user-specified and/or sponsor-specified locations with a reduced array (i.e. less than < 16) of electrodes". FDA records list 2 510(k) clearances for Forest Devices, Inc., from to . As of , FDA records show no recalls naming K242306.

Clearance record

Decision date
Received
(30 days to decision)
Product code
OMC Reduced- Montage Standard Electroencephalograph
Regulation
21 CFR 882.1400
Device class
Class II
Review panel
Neurology
Applicant
Forest Devices, Inc. 544 Miltenberger St., Pittsburgh PA
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code OMC

Trailing 12 months
2 clearances under product code OMC 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 OMC, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260