FDA 510(k) Application Details - K053248

Device Classification Name Percussor, Powered-Electric

  More FDA Info for this Device
510(K) Number K053248
Device Name Percussor, Powered-Electric
Applicant ELECTROMED, INC.
103 EDGECUMBE DRIVE
MAHTOMEDI, MN 55115 US
Other 510(k) Applications for this Company
Contact CHET SIEVERT
Other 510(k) Applications for this Contact
Regulation Number 868.5665

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

  More FDA Info for this Product Code
Date Received 11/21/2005
Decision Date 12/01/2005
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 Y
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact