← Back to catalogue

Oscillomate Blood Pressure Monitor-Model 915

FDA 510(k)

Class II (US FDA 510(k))

510(k) K860488

by Cas Medical Systems, Inc.

Identifiers

510(k) Number
K860488 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 Oscillomate Blood Pressure Monitor-Model 915 is a cardiovascular device designed for monitoring blood pressure. It functions as a noninvasive system used to track hemodynamic parameters.

This device is identified by K-number K860488 and has received FDA 510(k) clearance. It is manufactured by Cas Medical Systems, Inc. and is classified under product code DXN.

Frequently asked questions

What is the primary function of the Oscillomate Model 915?

The Oscillomate Model 915 is a cardiovascular device engineered to monitor blood pressure. It operates as a noninvasive system specifically designed to track hemodynamic parameters for clinical assessment.

What is the regulatory status of this device?

The Oscillomate Blood Pressure Monitor-Model 915 has received FDA 510(k) clearance under K-number K860488. It was determined to be substantially equivalent to existing devices by the FDA.

Who is the manufacturer of this blood pressure monitor?

This device is manufactured by Cas Medical Systems, Inc., located in Branford, Connecticut. The company submitted the device for review under the cardiovascular advisory committee.

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: OSCILLOMATE BLOOD PRESSURE MONITOR-MODEL 915 (K860488) — FDA 510(k ..., Oscillomate Blood Pressure Monitor-model 915 - Beudamed, PDF K860488 - Oscillomate Blood Pressure Monitor-model 915, 510(k) K860488 — OSCILLOMATE BLOOD PRESSURE MONITOR-MODEL 915

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Cas Medical Systems, Inc.

Sources (1)

  • FDA 510(k) K860488 24 fields · synced Oct 6, 2026