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. Radiology ✕

13 devices

1-13 of 13

Cleared Jan 22, 2001

VIEW READING STATION

Radiology · 53d

Cleared Apr 19, 2000

Radiology · 65d

Cleared Apr 15, 1999

Radiology · 38d

Cleared Jan 27, 1998

CD-R STATION AND VRS-2000

Radiology · 75d

Cleared Sep 03, 1997

VIEW ARCHIVING STATION

Radiology · 156d

Cleared Mar 31, 1995

Radiology · 45d

Cleared Feb 29, 1988

Radiology · 54d

Cleared Feb 01, 1988

Radiology · 33d

Cleared Jan 29, 1988

Radiology · 30d

Cleared Mar 31, 1987

EDEC 50C CONSTANT POTENTIAL X-RAY GENERATOR

Radiology · 8d

Cleared Mar 20, 1987

EDEC 80 CONSTANT POTENTIAL X-RAY GENERATOR

Radiology · 17d

Cleared Nov 29, 1985

Radiology · 143d

Cleared Mar 01, 1985

Radiology · 178d