FDA 510(k) Application Details - K040220

Device Classification Name Compressor, Air, Portable

  More FDA Info for this Device
510(K) Number K040220
Device Name Compressor, Air, Portable
Applicant EVENT MEDICAL LTD
6A LIOSBAN BUSINESS PARK
TUAM ROAD
GALWAY IE
Other 510(k) Applications for this Company
Contact ROBBIE WALSH
Other 510(k) Applications for this Contact
Regulation Number 868.6250

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

  More FDA Info for this Product Code
Date Received 02/02/2004
Decision Date 06/09/2004
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