FDA 510(k) Application Details - K172904

Device Classification Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

  More FDA Info for this Device
510(K) Number K172904
Device Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
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 868.1400

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

  More FDA Info for this Product Code
Date Received 09/22/2017
Decision Date 12/26/2017
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