MC 6000 Multi-Channel Electrocardiograph
by Cambridge Medical Instruments, Inc.
510(k) K871993
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK871993 | Date23 Nov 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- Withdrawn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
- DPS
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2340
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The MC 6000 Multi-Channel Electrocardiograph is a diagnostic device classified as an electrocardiograph (DPS product code). It records electrical activity of the heart across multiple channels simultaneously, enabling comprehensive assessment of cardiac function and rhythm disturbances. Designed for clinical use, it provides real-time visualization of ECG waveforms for diagnostic evaluation. The device supports multi-lead monitoring, facilitating detailed cardiac analysis in various patient settings.
This electrocardiograph is intended for use in clinical environments such as hospitals, cardiac care units, and physician offices. Supplied as a reusable medical device, it requires proper calibration and maintenance to ensure accurate readings. The MC 6000 holds an FDA 510(k) clearance (K871993) under the Traditional pathway, with a decision date of November 23, 1987. No specific sterility or MRI safety information is provided in the available data, and its operational specifications align with regulatory standards for electrocardiographic devices.
Other devices from Cambridge Medical Instruments, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the MC 6000 Multi-Channel Electrocardiograph used for?
The MC 6000 Multi-Channel Electrocardiograph is designed to record the electrical activity of the heart across multiple channels simultaneously. This enables healthcare professionals to perform comprehensive assessments of cardiac function and detect rhythm disturbances in real-time. It is particularly useful in clinical environments such as hospitals, cardiac care units, and physician offices for detailed cardiac analysis.
Is the MC 6000 Multi-Channel Electrocardiograph a reusable or single-use device?
The MC 6000 Multi-Channel Electrocardiograph is supplied as a reusable medical device. Like all reusable equipment, it requires proper calibration and maintenance to ensure accurate and reliable ECG readings over time. Regular upkeep is essential to sustain performance and compliance with clinical standards.
Does the MC 6000 Multi-Channel Electrocardiograph come with any sterility guarantees?
The available data does not specify any sterility information for the MC 6000 Multi-Channel Electrocardiograph. Since it is a reusable device, sterility would typically be managed through cleaning and disinfection protocols as part of routine maintenance procedures in clinical settings.
What regulatory pathway was followed for the MC 6000 Multi-Channel Electrocardiograph?
The MC 6000 Multi-Channel Electrocardiograph holds an FDA 510(k) clearance (K871993) under the Traditional pathway. This clearance was granted on November 23, 1987, and the device was determined to be substantially equivalent to a legally marketed predicate device. The clearance was reviewed by the Cardiovascular (CV) Advisory Committee.
What types of clinical settings is the MC 6000 Multi-Channel Electrocardiograph intended for?
The MC 6000 Multi-Channel Electrocardiograph is intended for use in clinical environments such as hospitals, cardiac care units, and physician offices. Its multi-lead monitoring capability makes it suitable for comprehensive cardiac assessments in diverse patient care settings where detailed ECG analysis is required.