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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K141806
Device Name CLEAR GUIDE ONE
Applicant
Clear Guide Medical
40 Warrenton Rd.
Baltimore,  MD  21210
Applicant Contact JACK KENT
Correspondent
Clear Guide Medical
40 Warrenton Rd.
Baltimore,  MD  21210
Correspondent Contact JACK KENT
Regulation Number892.1560
Classification Product Code
IYO  
Date Received07/03/2014
Decision Date 09/19/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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