Full Automatic (NIBP) Blood Pressure Monitor
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K150311 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 Full Automatic (NIBP) Blood Pressure Monitor is a noninvasive blood pressure measurement system that automatically measures human systolic, diastolic blood pressure and heart rate using the oscillometric method during inflation. All values are displayed on the LCD panel, with measurement taken at the upper arm position.
This device is supplied by Health & Life Co., Ltd. and is intended for single-use measurement of blood pressure and heart rate. It is authorized under FDA 510(k) clearance with regulation number 21 CFR 870.1130. The device is available in various models including HL858CP and HL858DK, with storage requirements as specified by the manufacturer.
Frequently asked questions
What is the Full Automatic (NIBP) Blood Pressure Monitor used for?
This device is a noninvasive blood pressure measurement system that automatically measures human systolic, diastolic blood pressure and heart rate using the oscillometric method during inflation. It is intended for single-use measurement of blood pressure and heart rate at the upper arm position.
How is the Full Automatic (NIBP) Blood Pressure Monitor supplied?
The device is supplied by Health & Life Co., Ltd. and is available in various models including HL858CP and HL858DK. It is intended for single-use measurement of blood pressure and heart rate, with storage requirements as specified by the manufacturer.
What is the regulatory status of the Full Automatic (NIBP) Blood Pressure Monitor?
The device is authorized under FDA 510(k) clearance with regulation number 21 CFR 870.1130. It has a decision code of SESE (Substantially Equivalent) and was reviewed by the Cardiovascular advisory committee. The K-number is K150311 and the product code is DXN.
How are the measurement values displayed on the Full Automatic (NIBP) Blood Pressure Monitor?
All measurement values including systolic blood pressure, diastolic blood pressure, and heart rate are displayed on the LCD panel of the device. The measurement is taken at the upper arm position using the oscillometric method during inflation.
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: Full Automatic(NIBP) Blood Pressure Monitor (K200521) — FDA 510(k ..., Full Automatic (NIBP) Blood Pressure Monitor by Health & Life Co. Ltd ..., Full Automatic (NIBP) Blood Pressure Monitor (K190507) — FDA 510 (k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K150311 | Class II | Active |
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Manufacturer
- Manufacturer
- Health & Life Co., Ltd.
Sources (1)
- FDA 510(k) K150311 24 fields · synced Oct 6, 2026