FDA 510(k) Application Details - K952797

Device Classification Name Device, Biofeedback

  More FDA Info for this Device
510(K) Number K952797
Device Name Device, Biofeedback
Applicant STOELTING CO.
620 WHEAT LN.
WOOD DALE, IL 60191 US
Other 510(k) Applications for this Company
Contact JJOHN ZIOBRO
Other 510(k) Applications for this Contact
Regulation Number 882.5050

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

  More FDA Info for this Product Code
Date Received 06/19/1995
Decision Date 04/17/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
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