Electronic Blood Pressure Monitors
by Hanson Scale Co. 510(k)
Active
510(k) K894062
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK894062 | Date24 Aug 1989 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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, 24 Sep 2026
The Electronic Blood Pressure Monitors are a noninvasive blood pressure measurement system. The device provides a signal from which systolic, diastolic, or mean blood pressures can be derived through the use of transducers placed on the surface of the body.
This device is identified by K894062 and has received FDA 510(k) clearance. It is manufactured by Hanson Scale Co. and is categorized under product code DXN.
Other devices from Hanson Scale Co.
Questions
AI-generated answers, 24 Sep 2026
How does this device measure blood pressure?
This system is noninvasive and utilizes transducers placed on the surface of the body to obtain signals. These signals are then processed to derive the patient's systolic, diastolic, and mean blood pressure readings.
What is the regulatory status of this monitor?
The Electronic Blood Pressure Monitor manufactured by Hanson Scale Co. has received FDA 510(k) clearance under the submission number K894062. It is classified under product code DXN and was determined to be substantially equivalent to existing devices.
Which medical specialty committee oversees this device?
This device is categorized under the Cardiovascular advisory committee, which is responsible for reviewing medical equipment related to heart and circulatory system functions.