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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Full-Montage Standard Electroencephalograph
510(k) Number K921485
Device Name LA MONT VIDEO PATIENT MONITORING SYSTEM
Applicant
MEDICAL SYSTEMS CORP.
SUITE 20/303 PACIFIC HIGHWAY
P.O. BOX 4O4, LINDFIELD
NWW 2070 AUSTRALIA,  AT
Applicant Contact TONY MONTGOMERY
Correspondent
MEDICAL SYSTEMS CORP.
SUITE 20/303 PACIFIC HIGHWAY
P.O. BOX 4O4, LINDFIELD
NWW 2070 AUSTRALIA,  AT
Correspondent Contact TONY MONTGOMERY
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received03/30/1992
Decision Date 10/22/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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