K827370Substantially Equivalent

Irex System II 2D/doppler Imaging System

Name: K827370 Irex System II 2D/doppler Imaging System
Creator: Irex Corp.
Published: 1982-06-28
License: https://open.fda.gov/license/

Irex Corp., Ramsey NJ / Traditional, Substantially Equivalent

FDA source

K827370 is the FDA 510(k) clearance record for IREX SYSTEM II 2D/DOPPLER IMAGING SYSTEM, cleared for Irex Corp. on 1982-06-28. FDA records list 3 510(k) clearances for Irex Corp., from 1982-06-28 to 1985-02-04. As of 2026-09-10, FDA records show no recalls naming K827370.

Clearance record

Decision date: 1982-06-28
Received: 1982-04-12 (77 days to decision)
Review panel: Unknown
Applicant: Irex Corp. 69 Spring St., Ramsey NJ
Third party review: No