Medical Device Manufacturer · US , Mchenry , IL

Electromed Intl., Ltd. - FDA 510(k) Cleared Devices

23 submissions · 23 cleared · Since 1981

23

Total

23

Cleared

0

Denied

FDA 510(k) Regulatory Record - Electromed Intl., Ltd. Cardiovascular ✕

9 devices

1-9 of 9

Cleared Dec 08, 1986

EM II DISPOSABLE ELECTRODE

Cardiovascular · 88d

Cleared Dec 08, 1986

EM II STRESS TEST ELECTRODE

Cardiovascular · 84d

Cleared Nov 20, 1986

EM III DISPOSABLE ELECTRODE

Cardiovascular · 50d

Cleared Aug 06, 1986

EM DIAGNOSTIC ECG ELECTRODE

Cardiovascular · 16d

Cleared May 08, 1986

EM STRESS ELECTRODE

Cardiovascular · 64d

Cleared Apr 17, 1986

Cardiovascular · 219d

Cleared Nov 30, 1982

CADIO-RESPIRATORY MONITOR #CR-2

Cardiovascular · 25d

Cleared Jul 20, 1982

CARDIO-RESPIRATORY MONITOR MODEL CR-1

Cardiovascular · 20d

Cleared Oct 13, 1981

INFANT CARIDAC MONITOR

Cardiovascular · 21d