FDA 510(k) Application Details - K003367

Device Classification Name Device, Biofeedback

  More FDA Info for this Device
510(K) Number K003367
Device Name Device, Biofeedback
Applicant SRS MEDICAL SYSTEMS, INC.
14950 N.E. 95TH ST.
REDMOND, WA 98052 US
Other 510(k) Applications for this Company
Contact LEE BRODY
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 10/30/2000
Decision Date 01/04/2001
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