510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K991853Substantially Equivalent

Interacoustics Ep 15 Abr Stand Alone Unit

Idem (Int'L Dist. of Electronics for Medicine), Benicia CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991853 is the FDA 510(k) clearance record for INTERACOUSTICS EP 15 ABR STAND ALONE UNIT, a class II device, cleared for Idem (Int'L Dist. of Electronics For Medicine) on under FDA product code GWJ (Stimulator, Auditory, Evoked Response). FDA records list 6 510(k) clearances for Idem (Int'L Dist. of Electronics For Medicine), from to . As of , FDA records show no recalls naming K991853.

Clearance record

Decision date
Received
(146 days to decision)
Product code
GWJ Stimulator, Auditory, Evoked Response
Regulation
21 CFR 882.1900
Device class
Class II
Review panel
Neurology
Applicant
Idem (Int'L Dist. of Electronics For Medicine) 4814 E. Second St., Benicia CA
510(k) summary
Summary
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