K862334Substantially Equivalent

Catalog No. I/a 100 and Kpe 200

Name: K862334 Catalog No. I/a 100 and Kpe 200
Creator: Ipax, Inc.
Published: 1986-07-08
License: https://open.fda.gov/license/

Ipax, Inc., Englewood CO / Traditional, Substantially Equivalent

FDA source

K862334 is the FDA 510(k) clearance record for CATALOG NO. I/A 100 AND KPE 200, cleared for Ipax, Inc. on 1986-07-08. FDA records list 16 510(k) clearances for Ipax, Inc., from 1986-06-04 to 2021-05-04. As of 2026-09-10, FDA records show no recalls naming K862334.

Clearance record

Decision date: 1986-07-08
Received: 1986-06-10 (28 days to decision)
Review panel: Unknown
Applicant: Ipax, Inc. 2109 W. Amherst Ave., Englewood CO
Third party review: No