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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 K203719
Device Name IntraSight Mobile
Applicant
Volcano Corporation
3721 Valley Centre Dr Ste 500
San Diego,  CA  92130
Applicant Contact Linda Schulz
Correspondent
Volcano Corporation
3721 Valley Centre Dr Ste 500
San Diego,  CA  92130
Correspondent Contact Linda Schulz
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Codes
DSA   DSK  
Date Received12/21/2020
Decision Date 01/19/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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