CAMSCAN SYSTEM

Detector And Alarm, Arrhythmia

AMERICAN OPTICAL CORP.

The following data is part of a premarket notification filed by American Optical Corp. with the FDA for Camscan System.

Pre-market Notification Details

Device IDK781845
510k NumberK781845
Device Name:CAMSCAN SYSTEM
ClassificationDetector And Alarm, Arrhythmia
Applicant AMERICAN OPTICAL CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDSI  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-11-01
Decision Date1978-11-20

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