Automatic Digital Electronic Wrist Blood Pressure Monitor Model Number WS-300
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K981702 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 Automatic Digital Electronic Wrist Blood Pressure Monitor Model Number WS-300 is an automatic digital wrist-mounted sphygmomanometer designed for home use by adult patients. It utilizes the oscillometric method to measure blood pressure and heart rate.
The device is supplied as a single-use item and is intended for use in a home setting. It is regulated under FDA Class 2 with a Traditional clearance type and has been authorized by the FDA under K Number K981702.
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: Automatic Digital Electronic Wrist Blood Pressure Monitor Model Number ..., Automatic Digital Electronic Wrist Blood Pressure Monitor Model Number ..., Automatic Digital Electronic Wrist Blood Pressure Monitor Model Number ..., fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K981702 | Class II | Active |
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Manufacturer
- Manufacturer
- Nihon Seimitsu Sokki Co., Ltd.
Sources (1)
- FDA 510(k) K981702 24 fields · synced Oct 6, 2026