Eclipse MINI Model 98900
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K212317 FDA 510(k)
- FDA Product Code
- MWJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2800 FDA 510(k)
- Regulation Number
- 870.2800 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Eclipse MINI Model 98900 is an ambulatory electrocardiograph (ECG) recorder designed for continuous, long-term monitoring of cardiac electrical activity. Classified as an ambulatory ECG recorder without analysis, it captures three-channel ECG data from a wearable patch sensor, enabling non-invasive assessment of heart rhythm and function over extended periods.
This device is supplied as a reusable, non-sterile medical instrument intended for clinical and home use. It is waterproof and capable of recording up to 30 days of ECG data, with the option for self-application by patients. The Eclipse MINI Model 98900 operates under FDA 510(k) clearance and MDR authorisation, adhering to regulatory standards for cardiovascular diagnostic devices. Storage and handling follow manufacturer guidelines to ensure device integrity and data accuracy.
Frequently asked questions
How long can the Eclipse MINI Model 98900 continuously record ECG data, and is it suitable for both clinical and home use?
The Eclipse MINI Model 98900 is designed for continuous ECG recording for up to 30 days, making it ideal for extended monitoring in both clinical and home settings. It is explicitly labeled as a reusable, non-sterile device, so it can be used in hospitals or by patients at home with proper training or self-application.
Is the Eclipse MINI Model 98900 waterproof, and how does this feature benefit its use?
Yes, the Eclipse MINI Model 98900 is waterproof, which allows for greater flexibility in patient use. This means it can withstand exposure to moisture, reducing the risk of damage during daily activities like showering or light exercise, and ensuring reliable ECG data capture even in less controlled environments.
What regulatory pathways has the Eclipse MINI Model 98900 followed, and what does this mean for its compliance?
The Eclipse MINI Model 98900 has undergone FDA 510(k) clearance and MDR (Medical Device Regulation) authorization, confirming its compliance with U.S. and EU cardiovascular diagnostic device standards. This ensures it meets stringent safety, performance, and quality requirements for monitoring cardiac electrical activity without integrated analysis.
Does the Eclipse MINI Model 98900 require sterilization, and how should it be stored to maintain data integrity?
The Eclipse MINI Model 98900 is non-sterile and reusable, so sterilization is not required. However, to preserve its functionality and ensure accurate ECG recordings, it must be stored and handled according to the manufacturer’s guidelines, which likely include protection from extreme temperatures, moisture, and physical damage.
What types of ECG data does the Eclipse MINI Model 98900 capture, and how is it applied to the patient?
The Eclipse MINI Model 98900 captures three-channel ECG data from a wearable patch sensor, enabling non-invasive monitoring of heart rhythm and function over extended periods. The device is designed for self-application by patients, meaning it can be easily attached by the user without requiring professional assistance, though proper placement is critical for accurate results.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF Diagnostic Patch Recorder Model 98900 Eclipse MINI - Spacelabs Healthcare, Spacelabs healthcare Eclipse MINI Manuals | ManualsLib, Spacelabs Healthcare Eclipse MINI Application Manual, K212317 - Eclipse MINI Model 98900 - Cardiovascular
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K212317 | Class II | Active |
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Manufacturer
- Manufacturer
- Spacelabs Healthcare Ltd
- FDA Applicant
- Spacelabs Healthcare, Ltd.
Sources (2)
- FDA 510(k) K212317 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026