Noninvasive Blood Pressure Monitor, Models MD-880B and MD-900T
510(k) K041789
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK041789 | Date15 Jul 2004 | 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- Withdrawn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, 24 Sep 2026
The Noninvasive Blood Pressure Monitor, Models MD-880B and MD-900T, is an oscillometric system designed to measure blood pressure and pulse rate. These devices utilize the oscillometric method to provide clinical readings for users.
These monitors are intended for use in a home care environment. The device is identified by K-number K041789 and has received FDA 510(k) clearance.
Other devices from Meditec Co., Ltd.
Questions
AI-generated answers, 24 Sep 2026
What is the primary function of the MD-880B and MD-900T monitors?
These devices are oscillometric systems designed to measure a user's blood pressure and pulse rate. They provide clinical readings using the oscillometric method.
Where are these blood pressure monitors intended to be used?
The MD-880B and MD-900T models are specifically intended for use in a home care environment, allowing users to monitor their vital signs outside of a clinical setting.
What is the regulatory status of these Meditec monitors?
These devices have received FDA 510(k) clearance under K-number K041789. This indicates that the devices were found to be substantially equivalent to legally marketed predicate devices.