Wristwatch Blood Pressure Monitor, Model A43
510(k) K010190
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK010190 | Date8 Feb 2001 | 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- Withdrawn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
- FDA applicant
- Rossmax Internationl , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1130
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 23 Sep 2026
The Wristwatch Blood Pressure Monitor, Model A43, is a non-invasive blood pressure measurement system. It is designed to monitor blood pressure levels for cardiovascular assessment.
This device is identified by 510(k) number K010190 and is classified under regulation number 870.1130. It has received FDA 510(k) clearance as a class 2 medical device.
Other devices from Rossmax Internationl, Ltd.
Questions
AI-generated answers, 23 Sep 2026
What is the primary purpose of the Model A43 monitor?
The Model A43 is a non-invasive blood pressure measurement system intended for monitoring blood pressure levels to assist in cardiovascular assessment.
What is the regulatory status of this device?
This device has received FDA 510(k) clearance as a class 2 medical device under the number K010190. It is classified under regulation number 870.1130.
Who is the manufacturer of the A43 blood pressure monitor?
The device is manufactured by Rossmax International, Ltd., based in Taipei, Taiwan.