Identifiers
- 510(k) Number
- K013033 FDA 510(k)
- FDA Product Code
- DXN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1130 FDA 510(k)
- Regulation Number
- 870.1130 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The HL168W Touch Screen is a medical device component designed for use in cardiovascular applications. It functions as a touch-based interface for the associated system.
This device is identified under FDA 510k clearance number K013033. It is manufactured by Health and Life Co., Ltd. and was determined to be substantially equivalent to existing devices.
Frequently asked questions
What is the primary function of the HL168W Touch Screen?
The HL168W Touch Screen is a medical device component engineered specifically for use as a touch-based interface within cardiovascular system applications.
What is the regulatory status of this device?
This device is identified under FDA 510k clearance number K013033, which indicates that the device was determined to be substantially equivalent to existing devices currently on the market.
Who is the manufacturer of the HL168W Touch Screen?
The HL168W Touch Screen is manufactured by Health & Life Co., Ltd., based in Taipei Hsien, Taiwan.
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: MODIFICATION TO: HL168W TOUCH SCREEN - Innolitics, K013033 - MODIFICATION TO: HL168W TOUCH SCREEN | FDA 510 (k), PDF K013033 - Modification To: Hl168w Touch Screen, Health Life Co L T D Taiwan FDA Filings - fda.report, Health & Life Co., Ltd FDA Filings - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K013033 | Class II | Active |
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Manufacturer
- Manufacturer
- Health & Life Co., Ltd.
Sources (1)
- FDA 510(k) K013033 24 fields · synced Oct 6, 2026