DYNAVISION 2000

Recorder, Attention Task Performance

PERFORMANCE ENT.

The following data is part of a premarket notification filed by Performance Ent. with the FDA for Dynavision 2000.

Pre-market Notification Details

Device IDK911938
510k NumberK911938
Device Name:DYNAVISION 2000
ClassificationRecorder, Attention Task Performance
Applicant PERFORMANCE ENT. 30 HAGERMAN BLVD. UNIONVILLE, ONTARIO, Canada, L3r 2a7,  CA
ContactPhil Jones
CorrespondentPhil Jones
PERFORMANCE ENT. 30 HAGERMAN BLVD. UNIONVILLE, ONTARIO, Canada, L3r 2a7,  CA
Product CodeLQD  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-05-01
Decision Date1991-08-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00860011067641 K911938 000
00860011067634 K911938 000
00860011067627 K911938 000
00860011067610 K911938 000

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