Healthteam Digital Blood Pressure Kit 8145
by Healthteam
510(k) K852458
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK852458 | Date30 Dec 1985 | 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- Withdrawn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, 26 Sep 2026
The Healthteam Digital Blood Pressure Kit 8145 is a noninvasive blood pressure measurement system. It provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of transducers placed on the surface of the body.
The device is supplied as a kit and is used for blood pressure measurement. It has been assigned the product code DXN and has received FDA 510K authorization with the decision code SESE. The kit is associated with the K number K852458.
Other devices from Healthteam
Questions
AI-generated answers, 26 Sep 2026
What is the Healthteam Digital Blood Pressure Kit 8145 used for?
The Healthteam Digital Blood Pressure Kit 8145 is used for noninvasive blood pressure measurement, providing systolic, diastolic, mean, or any combination of the three pressures.
How is the device supplied?
The device is supplied as a kit, including transducers for placement on the body surface.
What is the regulatory status of the Healthteam Digital Blood Pressure Kit 8145?
The device has received FDA 510K authorization with the decision code SESE, indicating it is substantially equivalent to a predicate device.