510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K830579Substantially Equivalent

Multi-Signal Auditory Stimulator Sm700

Nicolet Biomedical Instruments, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K830579 is the FDA 510(k) clearance record for MULTI-SIGNAL AUDITORY STIMULATOR SM700, a class II device, cleared for Nicolet Biomedical Instruments on under FDA product code GWJ (Stimulator, Auditory, Evoked Response). FDA records list 26 510(k) clearances for Nicolet Biomedical Instruments, from to . As of , FDA records show no recalls naming K830579.

Clearance record

Decision date
Received
(13 days to decision)
Product code
GWJ Stimulator, Auditory, Evoked Response
Regulation
21 CFR 882.1900
Device class
Class II
Review panel
Neurology
Applicant
Nicolet Biomedical Instruments 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GWJ

Trailing 12 months

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

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