510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K984052Substantially Equivalent

Synergy Iom System

Oxford Instruments Medical Systems, Crofton MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K984052 is the FDA 510(k) clearance record for SYNERGY IOM SYSTEM, a class II device, cleared for Oxford Instruments Medical Systems on under FDA product code IKN (Electromyograph, Diagnostic). FDA records list 5 510(k) clearances for Oxford Instruments Medical Systems, from to . As of , FDA records show no recalls naming K984052.

Clearance record

Decision date
Received
(185 days to decision)
Product code
IKN Electromyograph, Diagnostic
Regulation
21 CFR 890.1375
Device class
Class II
Review panel
Physical Medicine
Applicant
Oxford Instruments Medical Systems P.O. Box 4341, Crofton 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