BIOPSY ATTACHMENT;DYNEX ULTRASOUND-

System, Imaging, Pulsed Echo, Ultrasonic

ELSCINT, INC.

The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Biopsy Attachment;dynex Ultrasound-.

Pre-market Notification Details

Device IDK840451
510k NumberK840451
Device Name:BIOPSY ATTACHMENT;DYNEX ULTRASOUND-
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant ELSCINT, 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 Received1984-02-01
Decision Date1984-05-09

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