FDA 510(k) Application Details - K030943

Device Classification Name Valve, Non-Rebreathing

  More FDA Info for this Device
510(K) Number K030943
Device Name Valve, Non-Rebreathing
Applicant SENSOR MEDICS CORP.
22705 SAVI RANCH PKWY.
YORBA LINDA, CA 92887 US
Other 510(k) Applications for this Company
Contact EARL W DRAPER
Other 510(k) Applications for this Contact
Regulation Number 868.5870

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

  More FDA Info for this Product Code
Date Received 03/26/2003
Decision Date 04/22/2003
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