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Truly Automatic Arm Blood Pressure Monitor

FDA 510(k)

Class II (US FDA 510(k))

510(k) K113083

by Truly Instrument Co., Ltd.

Identifiers

510(k) Number
K113083 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 Truly Automatic Arm Blood Pressure Monitor is a non-invasive device designed to measure the systolic and diastolic blood pressure and pulse rate of an adult individual. It functions by using an inflatable cuff wrapped around the upper arm to obtain readings. The device also includes a feature for irregular pulse rhythm detection during measurement.

This device is available in models DB33, DB81, DB82, DB83, DB85, DB91, DB92, and DB93. It has received FDA 510(k) clearance under K113083. The monitor is intended for use in measuring blood pressure and pulse rate through non-invasive techniques.

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: TRULY AUTOMATIC ARM BLOOD PRESSURE MONITOR by TRULY INSTRUMENT CO., LTD ..., TRULY AUTOMATIC ARM BLOOD PRESSURE MONITOR (K113083) — FDA 510 (k ..., TRULY AUTOMATIC ARM BLOOD PRESSURE MONITOR by TRULY INSTRUMENT CO., LTD ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Truly Instrument Co., Ltd.

Sources (1)

  • FDA 510(k) K113083 24 fields · synced Oct 6, 2026