K837084Substantially Equivalent

Ultrasound Equipment Model Sdl-100A

Name: K837084 Ultrasound Equipment Model Sdl-100A
Creator: Elscint, Inc.
Published: 1983-04-28
License: https://open.fda.gov/license/

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

FDA source

K837084 is the FDA 510(k) clearance record for ULTRASOUND EQUIPMENT MODEL SDL-100A, cleared for Elscint, Inc. on 1983-04-28. 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 K837084.

Clearance record

Decision date: 1983-04-28
Received: 1983-01-25 (93 days to decision)
Review panel: Unknown
Applicant: Elscint, Inc. 505 Main St., Hackensack NJ
Third party review: No