FDA 510(k) Application Details - K123211

Device Classification Name Gas-Machine, Anesthesia

  More FDA Info for this Device
510(K) Number K123211
Device Name Gas-Machine, Anesthesia
Applicant DATASCOPE CORP., PATIENT MONITORING DIVISION
800 MACARTHUR BLVD.
MAHWAH, NJ 07430-0619 US
Other 510(k) Applications for this Company
Contact RUSSELL OLSEN
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 10/12/2012
Decision Date 02/14/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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