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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name recorder, attention task performance
510(k) Number K911938
Device Name DYNAVISION 2000
Applicant
PERFORMANCE ENT.
30 HAGERMAN BLVD.
UNIONVILLE, ONTARIO,
CANADA, L3R 2A7,  CA
Applicant Contact PHIL JONES
Correspondent
PERFORMANCE ENT.
30 HAGERMAN BLVD.
UNIONVILLE, ONTARIO,
CANADA, L3R 2A7,  CA
Correspondent Contact PHIL JONES
Classification Product Code
LQD  
Date Received05/01/1991
Decision Date 08/02/1991
Decision Substantially Equivalent (SESE)
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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