FDA 510(k) Application Details - K122223

Device Classification Name Monitor, Breathing Frequency

  More FDA Info for this Device
510(K) Number K122223
Device Name Monitor, Breathing Frequency
Applicant PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
HEWLETT-PACKARD STR. 2
BOEBLINGEN 71034 DE
Other 510(k) Applications for this Company
Contact MARKUS STACHA
Other 510(k) Applications for this Contact
Regulation Number 868.2375

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

  More FDA Info for this Product Code
Date Received 07/25/2012
Decision Date 04/12/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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