510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K821910Substantially Equivalent

Anesthesia & Brain Monitor

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

K821910 is the FDA 510(k) clearance record for ANESTHESIA & BRAIN MONITOR, a class II device, cleared for Datex Division Instrumentarium Corp. on under FDA product code IKN (Electromyograph, Diagnostic). FDA records list 55 510(k) clearances for Datex Division Instrumentarium Corp., from to . As of , FDA records show no recalls naming K821910.

Clearance record

Decision date
Received
(71 days to decision)
Product code
IKN Electromyograph, Diagnostic
Regulation
21 CFR 890.1375
Device class
Class II
Review panel
Physical Medicine
Applicant
Datex Division Instrumentarium Corp. 4221 Richmond Rd., NW, Walker MI
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