Fortec MI-100, MI-50 Digital Blood Pressure Meter
510(k) K873765
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK873765 | Date9 Oct 1987 | 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- Withdrawn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
- DSK
- FDA applicant
- Nam Tai , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1110
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
This device is a computer-based blood pressure meter, classified under the Cardiovascular medical specialty. It is designed to measure blood pressure digitally and is identified as substantially equivalent to a predicate device under FDA 510(k) clearance.
The device was cleared via the traditional 510(k) pathway with K873765 on October 9, 1987, by Nam Tai, Ltd. It is regulated under regulation number 870.1110 and assigned product code DSK. No information regarding sterility, single-use or reusable status, MRI safety, sizes, storage, or clinical setting is provided in the data.
Other devices from Nam Tai, Ltd.
Questions
AI-generated answers, 24 Sep 2026
What is the FORTEC MI-100 MI-50 Digital Blood Pressure Meter used for?
This device is designed to measure blood pressure digitally and is intended for use in cardiovascular medical settings to assess systolic and diastolic pressure non-invasively.
How is the FORTEC MI-100 MI-50 Digital Blood Pressure Meter supplied or configured for use?
The device is a computer-based blood pressure meter, meaning it operates as part of a digital system that processes and displays blood pressure readings electronically, though specific accessories or components are not detailed in the provided data.
Is the FORTEC MI-100 MI-50 Digital Blood Pressure Meter sterile or single-use?
The provided data does not include any information regarding sterility, single-use, or reusable status, so these characteristics cannot be confirmed from the available specifications.
What sizes or models are available for the FORTEC MI-100 MI-50 Digital Blood Pressure Meter?
The device is identified as the FORTEC MI-100, MI-50 Digital Blood Pressure Meter, indicating two model variants (MI-100 and MI-50) under the same product line, though specific size differences or technical distinctions between them are not described in the data.
What regulatory pathway was used for the FORTEC MI-100 MI-50 Digital Blood Pressure Meter?
The device received FDA 510(k) clearance through the traditional pathway under K873765 on October 9, 1987, and was determined to be substantially equivalent to a predicate device under regulation number 870.1110 and product code DSK.