Electrocardiograph SE-1200 Pro and SE-1201 Pro
510(k) K222902
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK222902 | Date28 Jul 2023 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
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, 18 Sep 2026
The Electrocardiograph SE-1200 Pro and SE-1201 Pro are portable, 12-lead electrocardiograph devices designed to record and display the electrical activity of the heart. These devices provide real-time ECG tracings, enabling clinicians to assess cardiac rhythm, detect abnormalities, and monitor patients for conditions such as arrhythmias, ischemia, or other cardiac disorders.
These devices are intended for use in clinical, pre-hospital, and emergency settings, supplied as reusable medical equipment. They are not sterile and require proper calibration and maintenance per manufacturer guidelines. The SE-1200 Pro and SE-1201 Pro are authorized under FDA 510(k) clearance (K222902) and comply with the EU Medical Device Regulation (MDR). Compatibility with MRI environments is not specified, and storage conditions should follow the manufacturer’s instructions.
Other devices from Edan Instruments, Inc.
Questions
AI-generated answers, 18 Sep 2026
Are the SE-1200 Pro and SE-1201 Pro devices single-use or reusable, and what does that mean for maintenance?
The SE-1200 Pro and SE-1201 Pro are designed as reusable medical devices, meaning they are built for repeated use in clinical, pre-hospital, or emergency settings. Since they are not sterile, they must be cleaned, calibrated, and maintained according to the manufacturer’s guidelines to ensure accurate ECG recordings and device longevity. Proper maintenance is critical to prevent signal interference or equipment failure during patient monitoring.
What types of cardiac conditions can these devices help detect, and how does the 12-lead capability assist clinicians?
These devices record and display real-time 12-lead ECG tracings, allowing clinicians to assess cardiac rhythm, identify abnormalities like arrhythmias or ischemia, and monitor for conditions such as myocardial infarction or other cardiac disorders. The 12-lead capability provides a comprehensive view of heart activity from multiple angles, improving diagnostic accuracy compared to single-lead or 3-lead systems.
How should these devices be stored, and are there any special considerations for their environment?
Storage conditions for the SE-1200 Pro and SE-1201 Pro should strictly follow the manufacturer’s instructions, though specific details like temperature or humidity ranges are not provided in the data. Since compatibility with MRI environments is not specified, they should not be used or stored near MRI machines unless confirmed safe by the manufacturer. Proper handling and storage are essential to preserve functionality and data integrity.
What regulatory pathways have these devices undergone, and how does that affect their use in the U.S. and EU?
The SE-1200 Pro and SE-1201 Pro are authorized under FDA 510(k) clearance (K222902), meaning they are deemed substantially equivalent to a legally marketed predicate device, allowing their use in the U.S. under FDA regulations. In the EU, they comply with the Medical Device Regulation (MDR), ensuring they meet stringent safety and performance standards for market placement. These clearances do not imply clinical indications but confirm regulatory compliance for their intended use.