DIGITAL VIDEO RECORDING SYSTEM

System, Image Processing, Radiological

KAY ELEMETRICS CORP.

The following data is part of a premarket notification filed by Kay Elemetrics Corp. with the FDA for Digital Video Recording System.

Pre-market Notification Details

Device IDK991738
510k NumberK991738
Device Name:DIGITAL VIDEO RECORDING SYSTEM
ClassificationSystem, Image Processing, Radiological
Applicant KAY ELEMETRICS CORP. 2 BRIDGEWATER LN. Lincoln Park,  NJ  07035 -1488
ContactWilliam D Harbeson
CorrespondentWilliam D Harbeson
KAY ELEMETRICS CORP. 2 BRIDGEWATER LN. Lincoln Park,  NJ  07035 -1488
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-05-21
Decision Date1999-08-13

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