Digital Blood Pressure Monitor Model HEM-703CP
510(k) K882393
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK882393 | Date30 Aug 1988 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DXN
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1130
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Digital Blood Pressure Monitor Model HEM-703CP is an automated device designed for measuring systolic and diastolic blood pressure and pulse rate. Classified under the product code DXN, it provides accurate readings through an oscillometric method, suitable for both clinical and home use. Its digital display enhances ease of use by automatically inflating the cuff and calculating results, reducing the need for manual adjustments. The device is intended for adults and is intended to be used by trained personnel or individuals familiar with blood pressure monitoring.
This device is supplied as a reusable, non-sterile instrument and is intended for single-patient use per session. It is not MRI-compatible and requires proper calibration and maintenance as specified in the manufacturer’s instructions. The cuff size is standard for adults, and the device should be stored in a clean, dry environment away from direct sunlight. Authorized for use in the United States under FDA 510(k) clearance (K882393), it adheres to regulatory standards for cardiovascular monitoring devices.