FDA 510(k) Application Details - K052176

Device Classification Name Spirometer, Diagnostic

  More FDA Info for this Device
510(K) Number K052176
Device Name Spirometer, Diagnostic
Applicant ZAN MESSGERATE GMBH
908 MAIN STREET
LOUISVILLE, CO 80027 US
Other 510(k) Applications for this Company
Contact JIM LEWIS
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 08/10/2005
Decision Date 01/12/2006
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