510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K000812Substantially Equivalent

Neuro Scan Medical Systems, Models 302L Medicor (Laboratory) and 302P Advantage 3000 (Portable)

Neurosoft Ltd, El Paso TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000812 is the FDA 510(k) clearance record for NEURO SCAN MEDICAL SYSTEMS, MODELS 302L MEDICOR (LABORATORY) AND 302P ADVANTAGE 3000 (PORTABLE), a class II device, cleared for Neurosoft, Inc. on under FDA product code IKN (Electromyograph, Diagnostic). FDA records list 7 510(k) clearances for Neurosoft, Inc., from to . As of , FDA records show no recalls naming K000812.

Clearance record

Decision date
Received
(65 days to decision)
Product code
IKN Electromyograph, Diagnostic
Regulation
21 CFR 890.1375
Device class
Class II
Review panel
Physical Medicine
Applicant
Neurosoft, Inc. 5700 Cromo Dr., El Paso TX
510(k) summary
Summary
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