Monitor, St Segment
The ST Segment Monitor is an electrocardiographic device that continuously analyzes the ECG signal to detect changes in the ST segment, which are indicative of myocardial ischemia or injury, and displays this information to assist clinicians in identifying and managing cardiac events in monitored patients. Classified as a Class 2 device under 21 CFR 870.2340 within the Cardiovascular specialty, it requires 510(k) premarket notification. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- MLC
- Device Class
- FDA class 2
- Regulation Number
- 870.2340
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.