FDA 510(k) Application Details - K962195

Device Classification Name Pad, Heating, Powered

  More FDA Info for this Device
510(K) Number K962195
Device Name Pad, Heating, Powered
Applicant SUNBEAM HEALTH DIVISION
7400 WEST 100TH PLACE
BRIDGEVIEW, IL 60455 US
Other 510(k) Applications for this Company
Contact FRANK BRICHETTO
Other 510(k) Applications for this Contact
Regulation Number 890.5740

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

  More FDA Info for this Product Code
Date Received 06/07/1996
Decision Date 11/27/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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