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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Therapeutic, X-Ray
510(k) Number K190255
Device Name Sensus Healthcare TVM Balloon Applicator
Applicant
Sensus Healthcare, Inc.
851 Broken Sound Pkwy. NW, Suite 215
Boca Raton,  FL  33487
Applicant Contact Nicolas Soro
Correspondent
Sensus Healthcare, Inc.
851 Broken Sound Pkwy. NW, Suite 215
Boca Raton,  FL  33487
Correspondent Contact Nicolas Soro
Regulation Number892.5900
Classification Product Code
JAD  
Date Received02/07/2019
Decision Date 02/21/2019
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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