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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stethoscope, Electronic
510(k) Number K210736
Device Name doctorgram Stethoscope DES-I
Applicant
GV Concepts
3240 S White Rd #286
San Jose,  CA  95148
Applicant Contact Ching-Kay Chow
Correspondent
GV Concepts
3034 Bradshaw Dr
San Jose,  CA  95148
Correspondent Contact Faye Liu
Regulation Number870.1875
Classification Product Code
DQD  
Date Received03/11/2021
Decision Date 07/27/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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