510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K884983Substantially Equivalent

M55 K Karaya Gum Disp. Microtape ECG Electrode, 55

S & W Medico Teknik, Denmark, DK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K884983 is the FDA 510(k) clearance record for M55 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 55, a class II device, cleared for S & W Medico Teknik on under FDA product code DRX (Electrode, Electrocardiograph). FDA records list 49 510(k) clearances for S & W Medico Teknik, from to . As of , FDA records show no recalls naming K884983.

Clearance record

Decision date
Received
(100 days to decision)
Product code
DRX Electrode, Electrocardiograph
Regulation
21 CFR 870.2360
Device class
Class II
Review panel
Cardiovascular
Applicant
S & W Medico Teknik Herstedvang 8, Denmark, DK
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