FDA 510(k) Application Details - K122365

Device Classification Name Antimicrobial Blood Pressure Cuff

  More FDA Info for this Device
510(K) Number K122365
Device Name Antimicrobial Blood Pressure Cuff
Applicant STATCORP MEDICAL
14476 Duval Pl W Ste 303
JACKSONVILLE, FL 32218 US
Other 510(k) Applications for this Company
Contact WAYNE EMMERT
Other 510(k) Applications for this Contact
Regulation Number 870.1120

  More FDA Info for this Regulation Number
Classification Product Code OED
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 08/06/2012
Decision Date 06/04/2013
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