FDA 510(k) Application Details - K190624

Device Classification Name Alarm, Blood-Pressure

  More FDA Info for this Device
510(K) Number K190624
Device Name Alarm, Blood-Pressure
Applicant Philips Medizin Systeme Boeblingen GmbH
Hewlett-Packard Strasse 2
Boeblingen 71034 DE
Other 510(k) Applications for this Company
Contact Greg Li
Other 510(k) Applications for this Contact
Regulation Number 870.1100

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

  More FDA Info for this Product Code
Date Received 03/11/2019
Decision Date 10/27/2019
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