K837181Substantially Equivalent

Eminex Ls-8 System

Name: K837181 Eminex Ls-8 System
Creator: Elscint, Inc.
Published: 1983-04-01
License: https://open.fda.gov/license/

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

FDA source

K837181 is the FDA 510(k) clearance record for EMINEX LS-8 SYSTEM, cleared for Elscint, Inc. on 1983-04-01. 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 K837181.

Clearance record

Decision date: 1983-04-01
Received: 1983-02-16 (44 days to decision)
Review panel: Unknown
Applicant: Elscint, Inc. 505 Main St., Hackensack NJ
Third party review: No