FDA 510(k) Application Details - K131945

Device Classification Name Gas-Machine, Anesthesia

  More FDA Info for this Device
510(K) Number K131945
Device Name Gas-Machine, Anesthesia
Applicant DATEX-OHMEDA
3030 OHMEDA DRIVE, P.O. BOX 7550
MADISON, WI 53707-7550 US
Other 510(k) Applications for this Company
Contact JAMES P RASKOB
Other 510(k) Applications for this Contact
Regulation Number 868.5160

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

  More FDA Info for this Product Code
Date Received 06/27/2013
Decision Date 08/08/2013
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