510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K840108Substantially Equivalent

Neuromuscular Transmission Monitor

Datex Division Instrumentarium Corp., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K840108 is the FDA 510(k) clearance record for NEUROMUSCULAR TRANSMISSION MONITOR, a class II device, cleared for Datex Division Instrumentarium Corp. on under FDA product code KOI (Stimulator, Nerve, Peripheral, Electric). FDA records list 55 510(k) clearances for Datex Division Instrumentarium Corp., from to . As of , FDA records show no recalls naming K840108.

Clearance record

Decision date
Received
(38 days to decision)
Product code
KOI Stimulator, Nerve, Peripheral, Electric
Regulation
21 CFR 868.2775
Device class
Class II
Review panel
Anesthesiology
Applicant
Datex Division Instrumentarium Corp. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code KOI

Trailing 12 months
1 clearance under product code KOI in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KOI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260