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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source Localization Software For Electroencephalograph Or Magnetoencephalograph
510(k) Number K984401
Device Name NEUROMAG VECTORVIEW
Applicant
Philips Medical Systems (Cleveland), Inc.
595 Miner Rd.
Cleveland,  OH  44143
Applicant Contact ELAINE K KEELER
Correspondent
Philips Medical Systems (Cleveland), Inc.
595 Miner Rd.
Cleveland,  OH  44143
Correspondent Contact ELAINE K KEELER
Regulation Number882.1400
Classification Product Code
OLX  
Subsequent Product Codes
GWQ   OLY  
Date Received12/09/1998
Decision Date 12/30/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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