MODIFICATION TO: HORIZON 9000WS— 510(k) K032997

Name: FDA 510(k) clearance K032997
Creator: U.S. Food and Drug Administration
Published: 2003-10-15

Substantially Equivalent

Mennen Medical , Ltd.

FDA 510(k) clearance K032997 for MODIFICATION TO: HORIZON 9000WS, Substantially Equivalent on 2003-10-15. Applicant: Mennen Medical , Ltd.. Device class: 2.

Clearance details

Applicant: Mennen Medical , Ltd.
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 2003-09-25
Decision date: 2003-10-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Yavne, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code DXG

view all

K253092 — Argos Infinity (Rev. 1.0)2026-02-13
K251275 — VitalStream ART Connect; VitalStream-Hemo2025-09-26
K232048 — Cogent Hemodynamic Monitoring System; Cogent HMS2023-12-20
K212529 — Hypotension Decision Assist Model HDA-OR22021-11-23
K192169 — PulsioFlex Monitoring System with ProAQT Sensor2020-04-30

More clearances from Mennen Medical , Ltd.

view all

Data sourced from openFDA. This site is unofficial and independent of the FDA.