KREMER CORNEOMETER ULTRASONIC PACHOMETER

System, Imaging, Pulsed Echo, Ultrasonic

ACCUTOME, INC.

The following data is part of a premarket notification filed by Accutome, Inc. with the FDA for Kremer Corneometer Ultrasonic Pachometer.

Pre-market Notification Details

Device IDK810660
510k NumberK810660
Device Name:KREMER CORNEOMETER ULTRASONIC PACHOMETER
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant ACCUTOME, 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 Received1981-03-11
Decision Date1981-08-21

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