Btl-08 Ecg Recorder Model Btl-08 Ecg Lc Plus, Btl-08 Ecg Lt Plus
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K100310 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 BTL-08 ECG Recorder is an ambulatory electrocardiograph device designed for monitoring and recording resting electrocardiograms. It features a patient database that enables the recording and storage of multiple 10-second records from all leads, as well as longer records from two selected leads.
This device is authorized under FDA 510(k) clearance. It supports printing on standard thermo-sensitive paper or via an external printer and can be used for ergometric examinations when connected to compatible software.
Frequently asked questions
What is the primary function of the BTL-08 ECG Recorder?
This device is an ambulatory electrocardiograph designed specifically for monitoring and recording resting electrocardiograms. It allows clinicians to capture and store multiple 10-second records from all leads, as well as longer duration records from two selected leads.
Can this device be used for ergometric examinations?
Yes, the BTL-08 ECG Recorder supports ergometric examinations when it is connected to compatible software, allowing for broader diagnostic utility in a clinical setting.
How are the electrocardiogram records printed?
The device supports printing through two methods: it can print directly onto standard thermo-sensitive paper or output data via an external printer, providing flexibility for documentation and patient records.
What is the regulatory status of this device?
The BTL-08 ECG Recorder models LC Plus and LT Plus are authorized under FDA 510(k) clearance, which indicates the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.
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 BTL-08 MT Plus BTL-08 LT BTL-08 LT Plus BTL-08 LC BTL-08 LC Plus ECG Series, 073-80 BTL-08 MT Plus<&LC ECG User Manual EN210 | PDF - Scribd, BTL-08 ECG User's Manual | Manualzz, PDF BTL-08 ECG Series - Industry Surplus Australia
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K100310 | Class II | Active |
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Manufacturer
- Manufacturer
- BTL Industries, Inc.
Sources (1)
- FDA 510(k) K100310 24 fields · synced Oct 6, 2026