FDA 510(k) Application Details - K962764

Device Classification Name Magnetoencephalograph

  More FDA Info for this Device
510(K) Number K962764
Device Name Magnetoencephalograph
Applicant PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
5500 AVION PARK DR.
HIGHLAND HEIGHTS, OH 44143 US
Other 510(k) Applications for this Company
Contact ELAINE K KEELER
Other 510(k) Applications for this Contact
Regulation Number 882.1400

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

  More FDA Info for this Product Code
Date Received 07/16/1996
Decision Date 10/31/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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