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FDA 510(k) Application Details - K210736
Device Classification Name
Stethoscope, Electronic
More FDA Info for this Device
510(K) Number
K210736
Device Name
Stethoscope, Electronic
Applicant
GV Concepts
3240 S White Rd #286
San Jose, CA 95148 US
Other 510(k) Applications for this Company
Contact
Ching-Kay Chow
Other 510(k) Applications for this Contact
Regulation Number
870.1875
More FDA Info for this Regulation Number
Classification Product Code
DQD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/11/2021
Decision Date
07/27/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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