MODEL SKI-200 ABDOMINAL SCANNER

System, Imaging, Pulsed Echo, Ultrasonic

SMITH KLINE DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Smith Kline Diagnostics, Inc. with the FDA for Model Ski-200 Abdominal Scanner.

Pre-market Notification Details

Device IDK800824
510k NumberK800824
Device Name:MODEL SKI-200 ABDOMINAL SCANNER
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant SMITH KLINE DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-04-14
Decision Date1980-05-14

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