510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K942965Substantially Equivalent

Computer Dyno/gonio/myo Graphy

Infotronic Medical Engineering, Severna Park MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K942965 is the FDA 510(k) clearance record for COMPUTER DYNO/GONIO/MYO GRAPHY, a class II device, cleared for Infotronic Medical Engineering on under FDA product code IKN (Electromyograph, Diagnostic). FDA records list one 510(k) clearance for Infotronic Medical Engineering. As of , FDA records show no recalls naming K942965.

Clearance record

Decision date
Received
(470 days to decision)
Product code
IKN Electromyograph, Diagnostic
Regulation
21 CFR 890.1375
Device class
Class II
Review panel
Physical Medicine
Applicant
Infotronic Medical Engineering 523 Benfield Rd., Severna Park MD
510(k) summary
Statement
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