K827744Substantially Equivalent

Dynex Ultrasound Diagnostic Scanner

Name: K827744 Dynex Ultrasound Diagnostic Scanner
Creator: Elscint, Inc.
Published: 1982-10-07
License: https://open.fda.gov/license/

Elscint, Inc., Hackensack NJ / Traditional, Substantially Equivalent

FDA source

K827744 is the FDA 510(k) clearance record for DYNEX ULTRASOUND DIAGNOSTIC SCANNER, cleared for Elscint, Inc. on 1982-10-07. FDA records list 94 510(k) clearances for Elscint, Inc., from 1981-09-16 to 1998-12-11. As of 2026-09-10, FDA records show no recalls naming K827744.

Clearance record

Decision date: 1982-10-07
Received: 1982-09-14 (23 days to decision)
Review panel: Unknown
Applicant: Elscint, Inc. 505 Main St., Hackensack NJ
Third party review: No