FDA 510(k) Application Details - K002343

Device Classification Name Vaporizer, Anesthesia, Non-Heated

  More FDA Info for this Device
510(K) Number K002343
Device Name Vaporizer, Anesthesia, Non-Heated
Applicant PENLON LTD.
Abingdon Science Park
Barton Lane, Abingdon OX14 3NB GB
Other 510(k) Applications for this Company
Contact ANTHONY PARSONS
Other 510(k) Applications for this Contact
Regulation Number 868.5880

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

  More FDA Info for this Product Code
Date Received 08/01/2000
Decision Date 06/08/2001
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