FDA 510(k) Application Details - K121144

Device Classification Name Stethoscope, Electronic

  More FDA Info for this Device
510(K) Number K121144
Device Name Stethoscope, Electronic
Applicant SHARP CORPORATION
1201 RICHARDSON DRIVE
SUITE 280
RICHARDSON, TX 75080 US
Other 510(k) Applications for this Company
Contact DIANE RUTHERFORD
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 04/16/2012
Decision Date 09/26/2012
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