FDA 510(k) Application Details - K052880

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

  More FDA Info for this Device
510(K) Number K052880
Device Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant GE HEALTHCARE
86 PILGRIM ROAD
NEEDHAM, MA 02492 US
Other 510(k) Applications for this Company
Contact JOEL C KENT
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 10/12/2005
Decision Date 11/02/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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