Medical Device Manufacturer · US , Mchenry , IL

Electromed Intl., Ltd.

23 submissions · 23 cleared · Since 1981
23
Total
23
Cleared
0
Denied

Electromed Intl., Ltd. — FDA 510(k) Submissions

Electromed Intl., Ltd. has submitted 23 FDA 510(k) premarket notifications since 1981, of which 23 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Generator, High-voltage, X-ray, Diagnostic, Electrode, Electrocardiograph, System, Image Processing, Radiological, Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm), Electrode, Cutaneous . Use the specialty filter in the sidebar to narrow results.

23 devices
1–23 of 23
VIEW READING STATION
K003688 · LLZ System, Image Processing,... · Radiology
Jan 2001 53d
VIEW NT
K000474 · LLZ System, Image Processing,... · Radiology
Apr 2000 65d
VIEW COM
K990759 · LLZ System, Image Processing,... · Radiology
Apr 1999 38d
CD-R STATION AND VRS-2000
K974255 · LMD System, Digital Image... · Radiology
Jan 1998 75d
VIEW ARCHIVING STATION
K971176 · IZI System, X-ray, Angiographic · Radiology
Sep 1997 156d
COMPACT-X
K950694 · IZO Generator, High-voltage,... · Radiology
Mar 1995 45d
EDEC 60R
K880050 · IZO Generator, High-voltage,... · Radiology
Feb 1988 54d
EDEC 60 R/F
K875341 · IZO Generator, High-voltage,... · Radiology
Feb 1988 33d
EDEC 90C
K875342 · IZO Generator, High-voltage,... · Radiology
Jan 1988 30d
EDEC 50C CONSTANT POTENTIAL X-RAY GENERATOR
K871145 · IZO Generator, High-voltage,... · Radiology
Mar 1987 8d
EDEC 80 CONSTANT POTENTIAL X-RAY GENERATOR
K870851 · IZO Generator, High-voltage,... · Radiology
Mar 1987 17d
EM TENS WINDOW ELECTRODES
K864032 · GXY Electrode, Cutaneous · Neurology
Dec 1986 68d
EM II DISPOSABLE ELECTRODE
K863540 · DRX Electrode,... · Cardiovascular
Dec 1986 88d
EM II STRESS TEST ELECTRODE
K863584 · DRX Electrode,... · Cardiovascular
Dec 1986 84d
EM III DISPOSABLE ELECTRODE
K863845 · DRX Electrode,... · Cardiovascular
Nov 1986 50d
EM DIAGNOSTIC ECG ELECTRODE
K862746 · DRX Electrode,... · Cardiovascular
Aug 1986 16d
EM STRESS ELECTRODE
K860827 · DRX Electrode,... · Cardiovascular
May 1986 64d
EM ELECTRODE
K853774 · DRX Electrode,... · Cardiovascular
Apr 1986 219d
EDEC 2000
K852908 · IZO Generator, High-voltage,... · Radiology
Nov 1985 143d
EDEC-100
K843443 · IZO Generator, High-voltage,... · Radiology
Mar 1985 178d
CADIO-RESPIRATORY MONITOR #CR-2
K823312 · DRT Monitor, Cardiac (incl.... · Cardiovascular
Nov 1982 25d
CARDIO-RESPIRATORY MONITOR MODEL CR-1
K821959 · DRT Monitor, Cardiac (incl.... · Cardiovascular
Jul 1982 20d
INFANT CARIDAC MONITOR
K812674 · DRT Monitor, Cardiac (incl.... · Cardiovascular
Oct 1981 21d
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