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Unisonic Electronic Digital Bp Monitor Ebm-3050

FDA 510(k)

Class II (US FDA 510(k))

510(k) K850317

by Nihon Seimitsu Sokki Co., Ltd.

Identifiers

510(k) Number
K850317 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 Unisonic Electronic Digital Blood Pressure Monitor EBM-3050 is an automated device designed for measuring and displaying blood pressure readings. Classified under the product code DXN, it provides digital output of systolic and diastolic pressure, functioning as a standalone unit for clinical or home use. Its electronic design ensures accuracy and repeatability in blood pressure assessment, supporting cardiovascular monitoring.

This device is supplied as a reusable, non-sterile medical instrument intended for clinical settings. It operates on standard electrical power and requires no special storage conditions beyond a clean, dry environment. The EBM-3050 holds an FDA 510(k) clearance under the traditional pathway, with a decision date of April 16, 1985, and is regulated under the Cardiovascular advisory committee. No MRI safety classification or single-use designation is specified.

Frequently asked questions

What is the Unisonic EBM-3050 Digital BP Monitor used for?

The Unisonic EBM-3050 is an automated electronic device designed to measure and display blood pressure readings. It provides digital output of systolic and diastolic pressure, making it suitable for both clinical and home use. Its electronic design ensures precision and repeatability, supporting cardiovascular monitoring in patients.

Is the EBM-3050 a single-use or reusable device?

The EBM-3050 is supplied as a reusable, non-sterile medical instrument. It is intended for repeated use in clinical settings, provided it is maintained in a clean and dry environment. Reusability is common for durable electronic devices like this one, reducing waste and cost over time.

What are the storage requirements for the EBM-3050?

The device requires no special storage conditions beyond keeping it in a clean and dry environment. This ensures optimal functionality and longevity. Avoid exposing it to extreme temperatures, moisture, or direct sunlight, as these factors could affect performance.

Does the EBM-3050 have FDA clearance, and what pathway was used?

Yes, the Unisonic EBM-3050 holds FDA 510(k) clearance under the traditional pathway. The clearance was granted on April 16, 1985, and it is regulated under the Cardiovascular advisory committee. This means the device was evaluated for substantial equivalence to a predicate device already on the market.

Can the EBM-3050 be used in an MRI environment?

The device does not specify an MRI safety classification in its documentation. As a general precaution, electronic medical devices should not be used near MRI machines unless explicitly labeled as MRI-safe. Always verify compatibility with your facility’s MRI protocols before use.

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: Unisonic Electronic Digital Bp Monitor Ebm-3050, PDF K850317 Unisonic Electronic Digital Bp Monitor Ebm-3050, NIHON SEIMITSU SOKKI CO.,LTD.Japan | Blood pressure,Thermometer,Pulse ..., Technical Data | NIHON SEIMITSU SOKKI CO.,LTD.Japan, Unisonic Electronic Digital Bp Monitor Ebm-2050

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nihon Seimitsu Sokki Co., Ltd.

Sources (1)

  • FDA 510(k) K850317 24 fields · synced Oct 1, 2026