AUTO-MATE CAMERA

System, Imaging, Pulsed Echo, Ultrasonic

APTEK LTD.

The following data is part of a premarket notification filed by Aptek Ltd. with the FDA for Auto-mate Camera.

Pre-market Notification Details

Device IDK803157
510k NumberK803157
Device Name:AUTO-MATE CAMERA
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant APTEK LTD. 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 Received1980-12-04
Decision Date1981-02-02

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