Modification to MAC 5000 ECG Analysis System
by GE Medical Systems Information Technologies 2 variants
510(k) K033492
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK033492 | Date24 Nov 2003 | 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- Withdrawn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
- MHX
- Device class
- Class II
- Regulation
- 21 CFR Part 870.1025
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The device is a modification to the MAC 5000 ECG Analysis System, which is intended to acquire, analyze, display, and record electrocardiographic information for adult and pediatric populations. It delivers 3, 6, 12, or 15 lead ECGs, 12 lead interpretive analysis, vector loops, and can be upgraded to provide software analysis options such as high resolution signal averaging of QRS.
The system is intended to be used under the direct supervision of a licensed healthcare practitioner by trained operators in a hospital or medical professional's facility environment to record ECG signals from surface electrodes. It is supplied as a physiological monitor with arrhythmia detection or alarms, classified as a Class II device under FDA regulation number 870.1025, and received FDA 510(k) clearance (K033492) on November 24, 2003, as substantially equivalent to a predicate device.
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Questions
AI-generated answers, 1 Oct 2026
What is the Modification to MAC 5000 ECG Analysis System used for?
It is intended to acquire, analyze, display, and record electrocardiographic information for adult and pediatric populations, delivering 3, 6, 12, or 15 lead ECGs with 12 lead interpretive analysis, vector loops, and optional software upgrades like high resolution signal averaging of QRS.
Who is intended to operate the Modification to MAC 5000 ECG Analysis System?
The system is designed to be used under the direct supervision of a licensed healthcare practitioner by trained operators in a hospital or medical professional's facility environment to record ECG signals from surface electrodes.
How was the Modification to MAC 5000 ECG Analysis System regulated and cleared?
It received FDA 510(k) clearance (K033492) on November 24, 2003, as substantially equivalent to a predicate device, and is classified as a Class II device under FDA regulation number 870.1025.