ULTRA IMAGER 2000

System, Imaging, Pulsed Echo, Ultrasonic

HONEYWELL, INC.

The following data is part of a premarket notification filed by Honeywell, Inc. with the FDA for Ultra Imager 2000.

Pre-market Notification Details

Device IDK834282
510k NumberK834282
Device Name:ULTRA IMAGER 2000
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant HONEYWELL, INC. IN 
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-11-21
Decision Date1984-04-23

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