FDA 510(k), K971329, CTF SYSTEMS INC, WHOLE-CORTEX MEG SYSTEM (WITH OPTIONAL EEG SUBSYSTEM)
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
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Total Pages: 671
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Fully Redacted Pages: 87
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Content Pages: 584
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