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Electromed Intl., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
23
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K003688VIEW READING STATIONJanuary 22, 2001
K000474VIEW NTApril 19, 2000
K990759VIEW COMApril 15, 1999
K974255CD-R STATION AND VRS-2000January 27, 1998
K971176VIEW ARCHIVING STATIONSeptember 3, 1997
K950694COMPACT-XMarch 31, 1995
K880050EDEC 60RFebruary 29, 1988
K875341EDEC 60 R/FFebruary 1, 1988
K875342EDEC 90CJanuary 29, 1988
K871145EDEC 50C CONSTANT POTENTIAL X-RAY GENERATORMarch 31, 1987
K870851EDEC 80 CONSTANT POTENTIAL X-RAY GENERATORMarch 20, 1987
K864032EM TENS WINDOW ELECTRODESDecember 22, 1986
K863540EM II DISPOSABLE ELECTRODEDecember 8, 1986
K863584EM II STRESS TEST ELECTRODEDecember 8, 1986
K863845EM III DISPOSABLE ELECTRODENovember 20, 1986
K862746EM DIAGNOSTIC ECG ELECTRODEAugust 6, 1986
K860827EM STRESS ELECTRODEMay 8, 1986
K853774EM ELECTRODEApril 17, 1986
K852908EDEC 2000November 29, 1985
K843443EDEC-100March 1, 1985