FDA 510(k), K971329, CTF SYSTEMS INC, WHOLE-CORTEX MEG SYSTEM (WITH OPTIONAL EEG SUBSYSTEM)

510(K) Number: K971329
Device Name: CTF SYSTEMS INC, WHOLE-CORTEX MEG SYSTEM (WITH OPTIONAL EEG SUBSYSTEM)
Manufacturer: STEPHEN E ROBINSON
Device Classification Name: Full-Montage Standard Electroencephalograph
Regulation Number: GWQ
Classification Product Code: KXA
Date Received: 04/10/1997
Decision Date: 11/20/1997
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology

• Total Pages: 671

• Fully Redacted Pages: 87

• Content Pages: 584