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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Ultrasonic, Nonfetal
510(k) Number K010521
Device Name NICOLET VERSALAB
Applicant
Nicolet Biomedical
6355 Joyce Dr.
Golden,  CO  80403
Applicant Contact DAVID W WAGNER
Correspondent
Nicolet Biomedical
6355 Joyce Dr.
Golden,  CO  80403
Correspondent Contact DAVID W WAGNER
Regulation Number892.1540
Classification Product Code
JAF  
Subsequent Product Code
JOP  
Date Received02/22/2001
Decision Date 03/09/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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