FDA 510(k) Application Details - K974255

Device Classification Name	System, Digital Image Communications, Radiological   More FDA Info for this Device
510(K) Number	K974255
Device Name	System, Digital Image Communications, Radiological
Applicant	ELECTROMED INTL., LTD. 310 INDUSTRIAL BLVD. ST-EUSTACHE, QUEBEC J7R 5R4 CA Other 510(k) Applications for this Company
Contact	JAMES RIEDL Other 510(k) Applications for this Contact
Regulation Number	892.2020   More FDA Info for this Regulation Number
Classification Product Code	LMD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/13/1997
Decision Date	01/27/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review