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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact