← Back to catalogue

Blood Pressure Meter, Model CH-658

FDA 510(k)

Class II (US FDA 510(k))

510(k) K102303

by Citizen Systems Japan Co., Ltd.

Identifiers

510(k) Number
K102303 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 Blood Pressure Meter, Model CH-658, is an oscillometric device designed for non-invasive measurement of systolic and diastolic blood pressure, as well as pulse rate. It employs an inflatable cuff wrapped around the wrist to assess cardiovascular parameters accurately.

This device is intended for home or clinical use and is classified as a Class II medical device under FDA regulations. Supplied as a reusable electronic instrument, it requires no sterilisation but must be maintained per manufacturer guidelines. The Model CH-658 holds an FDA 510(k) clearance (K102303) with a decision of Substantially Equivalent, authorised for distribution by Citizen Systems Japan Co., Ltd.

Frequently asked questions

What is the purpose of the Blood Pressure Meter Model CH-658?

The Blood Pressure Meter Model CH-658 is designed for non-invasive measurement of systolic and diastolic blood pressure, as well as pulse rate, using an inflatable cuff wrapped around the wrist.

Is the Blood Pressure Meter Model CH-658 reusable or single-use?

The device is supplied as a reusable electronic instrument that requires no sterilization but must be maintained according to manufacturer guidelines.

What are the regulatory authorizations for the Blood Pressure Meter Model CH-658?

The device holds FDA 510(k) clearance (K102303) with a decision of Substantially Equivalent, authorized for distribution by Citizen Systems Japan Co., Ltd.

Where can the Blood Pressure Meter Model CH-658 be used?

This device is intended for both home and clinical use to measure cardiovascular parameters accurately.

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: BLOOD PRESSURE METER, MODEL CH-658 - Innolitics, BLOOD PRESSURE METER, MODEL CH-658 - fda.report, Blood Pressure Meter, Model Ch-658 - Beudamed, 510(k) Premarket Notification, Digital blood pressure monitor | CITIZEN SYSTEMS JAPAN CO.,LTD.

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
Citizen Systems Japan Co., Ltd.

Sources (1)

  • FDA 510(k) K102303 24 fields · synced Sep 19, 2026