510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K950473Substantially Equivalent

Disposable ECG Monitoring Electrode

Nikomed U.S.A., Inc., Doylestown PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950473 is the FDA 510(k) clearance record for DISPOSABLE ECG MONITORING ELECTRODE, a class II device, cleared for Nikomed U.S.A., Inc. on under FDA product code DRX (Electrode, Electrocardiograph). FDA records list 15 510(k) clearances for Nikomed U.S.A., Inc., from to . As of , FDA records show no recalls naming K950473.

Clearance record

Decision date
Received
(312 days to decision)
Product code
DRX Electrode, Electrocardiograph
Regulation
21 CFR 870.2360
Device class
Class II
Review panel
Cardiovascular
Applicant
Nikomed U.S.A., Inc. 206 Airport Blvd., Doylestown PA
510(k) summary
Statement
Third party review
No

Clearances, product code DRX

Trailing 12 months

FDA records hold no clearances under product code DRX in the trailing twelve months.

FDA records show no clearances under product code DRX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DRX, 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