Truscope Series Patient Monitor
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K131763 FDA 510(k)
- FDA Product Code
- MHX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1025 FDA 510(k)
- Regulation Number
- 870.1025 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Truscope Series Patient Monitor is a physiological patient monitor with arrhythmia detection or alarms. It is designed for monitoring various patient parameters in clinical settings.
The device is supplied by Guangdong Biolight Meditech Co., Ltd. and has FDA 510(k) clearance with product code MHX. It is available in multiple models including Truscope Elite A8, Truscope Elite A6, Truscope Elite A5, and Truscope Elite A3. The device is regulated under cardiovascular specialty and is intended for use in patient monitoring applications.
Frequently asked questions
What is the Truscope Series Patient Monitor used for?
The Truscope Series Patient Monitor is designed for monitoring various patient parameters in clinical settings, with specific arrhythmia detection capabilities to alert healthcare providers to irregular heart rhythms.
What models are available in the Truscope Series?
The Truscope Series is available in multiple models including the Truscope Elite A8, Truscope Elite A6, Truscope Elite A5, and Truscope Elite A3, each offering different configurations to meet various clinical monitoring needs.
What is the regulatory status of the Truscope Series Patient Monitor?
The Truscope Series Patient Monitor has FDA 510(k) clearance with product code MHX, classified under cardiovascular specialty, and is regulated as a Class II medical device for patient monitoring applications.
Who manufactures the Truscope Series Patient Monitor?
The Truscope Series Patient Monitor is manufactured by Guangdong Biolight Meditech Co., Ltd., a company based in Shanghai, China, with contact person Diana Hong.
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: Guangdong Biolight Meditech Co., Ltd., Products_Guangdong Biolight Meditech Co., Ltd., Guangdong Biolight Meditech Co., Ltd. FDA 510(k) Products (2008-2019), TRUSCOPE SERIES PATIENT MONITOR (K131763) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K131763 | Class II | Active |
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Manufacturer
- Manufacturer
- Guangdong Biolight Meditech Co., Ltd
- FDA Applicant
- Guangdong Biolight Meditech Co., Ltd.
Sources (1)
- FDA 510(k) K131763 24 fields · synced Oct 6, 2026