FDA 510(k) Application Details - K020004

Device Classification Name Spirometer, Diagnostic

  More FDA Info for this Device
510(K) Number K020004
Device Name Spirometer, Diagnostic
Applicant COMPLEWARE CORP.
221 EAST BURLINGTON ST.
IOWA CITY, IA 52240 US
Other 510(k) Applications for this Company
Contact KAY WEILER
Other 510(k) Applications for this Contact
Regulation Number 868.1840

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

  More FDA Info for this Product Code
Date Received 01/02/2002
Decision Date 07/24/2002
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