510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863584Substantially Equivalent

Em II Stress Test Electrode

Electromed Intl., Ltd., Waltham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863584 is the FDA 510(k) clearance record for EM II STRESS TEST ELECTRODE, a class II device, cleared for Electromed Intl., Ltd. on under FDA product code DRX (Electrode, Electrocardiograph). FDA records list 23 510(k) clearances for Electromed Intl., Ltd., from to . As of , FDA records show no recalls naming K863584.

Clearance record

Decision date
Received
(84 days to decision)
Product code
DRX Electrode, Electrocardiograph
Regulation
21 CFR 870.2360
Device class
Class II
Review panel
Cardiovascular
Applicant
Electromed Intl., Ltd. 34 Bear Hill Rd., Waltham MA
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