FDA 510(k) Application Details - K180430

Device Classification Name	System,Network And Communication,Physiological Monitors   More FDA Info for this Device
510(K) Number	K180430
Device Name	System,Network And Communication,Physiological Monitors
Applicant	ASCOM UMS srl unipersonale Via Amilcare Ponchielli 29 Scandicci (FI) 50018 IT Other 510(k) Applications for this Company
Contact	Paolo Burchietti Other 510(k) Applications for this Contact
Regulation Number	870.2300   More FDA Info for this Regulation Number
Classification Product Code	MSX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/16/2018
Decision Date	11/23/2018
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