510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K002104Substantially Equivalent

Combined Physiological Monitoring System

Maryrose Cusimano, Ph.D. & Scott Zeff, Ft. Lauderdale FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K002104 is the FDA 510(k) clearance record for COMBINED PHYSIOLOGICAL MONITORING SYSTEM, a class II device, cleared for Maryrose Cusimano, Ph.D. & Scott Zeff on under FDA product code IKN (Electromyograph, Diagnostic). FDA records list one 510(k) clearance for Maryrose Cusimano, Ph.D. & Scott Zeff. As of , FDA records show no recalls naming K002104.

Clearance record

Decision date
Received
(90 days to decision)
Product code
IKN Electromyograph, Diagnostic
Regulation
21 CFR 890.1375
Device class
Class II
Review panel
Physical Medicine
Applicant
Maryrose Cusimano, Ph.D. & Scott Zeff 7481 W. Oakland Park Blvd., Ft. Lauderdale FL
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