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510(k) Premarket Notification Database

Device Classification Name system, image processing, radiological
510(k) NumberK973065
Device NameREALVIEW TELEMEDICINE SYSTEM
Applicant
VCOM SYSTEMS, INC.
809 north dixie hwy., #200
west palm beach,  FL  33401
Contactwayne b jacobs
Regulation Number892.2050
Classification Product Code
LLZ
Date Received08/18/1997
Decision Date 11/13/1997
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
Statement/Summary/Purged Status Statement/purged 510(k)
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No

Database Updated 02/06/2009

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