SKI 5000

Echocardiograph

SMITH KLINE DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Smith Kline Diagnostics, Inc. with the FDA for Ski 5000.

Pre-market Notification Details

Device IDK812646
510k NumberK812646
Device Name:SKI 5000
ClassificationEchocardiograph
Applicant SMITH KLINE DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDXK  
CFR Regulation Number870.2330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-09-17
Decision Date1981-11-16

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