Model {m-102 I-Channel Electro Cardiograph Unit
by Future Impex Corp. 510(k)
Active
510(k) K843934
Overview
The Model M-102 I-Channel Electrocardiograph Unit is a single-channel electrocardiograph device designed to record the electrical activity of the heart. It falls under the FDA product code DPS, classified as an electrocardiograph under 21 CFR 870.2340, and is intended for clinical use in monitoring cardiac rhythms and diagnosing cardiac conditions.
This device is supplied as a reusable medical instrument and is regulated under the FDA’s 510(k) clearance process, with authorization granted on November 20, 1984. It is intended for use in healthcare settings such as hospitals, clinics, or physician offices, adhering to standard electrocardiographic procedures. The device’s regulatory classification and clearance status are documented under the traditional 510(k) pathway, with no indication of third-party review.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK843934 | Date20 Nov 1984 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
- DPS
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2340
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Future Impex Corp.
Questions
What is the primary purpose of the Model M-102 I-Channel Electrocardiograph Unit in clinical settings?
The Model M-102 is designed to record the electrical activity of the heart, specifically to monitor cardiac rhythms and assist in diagnosing cardiac conditions. It is a single-channel electrocardiograph, meaning it captures one lead at a time, which is standard for basic cardiac assessments in hospitals, clinics, or physician offices.
Is the Model M-102 a single-use or reusable device, and what does that mean for maintenance?
The Model M-102 is a reusable medical instrument, meaning it is intended for repeated use after proper cleaning, disinfection, and maintenance. Since it is not single-use, healthcare facilities must follow established protocols for reprocessing to ensure safety and functionality between patients.
How was the regulatory approval for this device obtained, and what does that mean for its use?
The Model M-102 received FDA clearance through the traditional 510(k) pathway, which demonstrates it was determined to be substantially equivalent to a legally marketed device already on the market. This means it meets FDA standards for safety and effectiveness as established for electrocardiograph units, allowing its use in clinical settings for cardiac monitoring and diagnostics.
What type of healthcare environments is this device intended for, and why?
The Model M-102 is intended for use in standard healthcare settings such as hospitals, clinics, or physician offices. Its design aligns with typical electrocardiographic procedures, making it suitable for environments where basic cardiac assessments are performed, such as routine check-ups, emergency rooms, or cardiac care units.