FDA 510(k) Application Details - K961212

Device Classification Name Goniometer, Ac-Powered

  More FDA Info for this Device
510(K) Number K961212
Device Name Goniometer, Ac-Powered
Applicant FASSTECH
155 MIDDLESEX TURNPIKE
BURLINGTON, MA 01803 US
Other 510(k) Applications for this Company
Contact LEE R BRODY
Other 510(k) Applications for this Contact
Regulation Number 888.1500

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

  More FDA Info for this Product Code
Date Received 03/28/1996
Decision Date 06/12/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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