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Horizon 2000 Non-invasive Blood Pressure Cap

FDA 510(k)

Class II (US FDA 510(k))

510(k) K854942

by Mennen Medical, Inc.

Identifiers

510(k) Number
K854942 FDA 510(k)
FDA Product Code
DXN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1130 FDA 510(k)
Regulation Number
870.1130 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Horizon 2000 Non-invasive Blood Pressure Cap is a medical device designed for the monitoring of blood pressure. It functions as a component within a physiological patient monitoring system to obtain non-invasive pressure readings.

This device is manufactured by Mennen Medical, Inc. and has received FDA 510(k) clearance under the reference number K854942. It is categorized under the cardiovascular advisory committee for regulatory purposes.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Horizon 2000 Non-invasive Blood Pressure Cap., Horizon 2000 Non-invasive Blood Pressure Cap. - Beudamed, PDF K854942 - Horizon 2000 Non-invasive Blood Pressure Cap., Mennen Medical, Inc. FDA 510 (k) Products (1985-2004), Horizon 2000 Physiological Patient Monitor 510 (k) FDA Premarket ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Mennen Medical, Inc.

Sources (1)

  • FDA 510(k) K854942 24 fields · synced Oct 6, 2026