Identifiers
- 510(k) Number
- K033043 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 Modification to HL168 is a cardiovascular device, classified under product code DXN, intended for use in diagnostic or monitoring procedures related to the heart. It represents a modified version of an existing device, maintaining its core functionality while incorporating updated specifications or features to ensure continued safety and performance.
This device is supplied by Health & Life Co., Ltd. and has undergone a premarket notification review by the FDA under 510(k) clearance (K033043), classified as substantially equivalent with a special review pathway. It is intended for single-use or reusable applications in clinical settings, though specific sterility, MRI safety, or storage conditions are not detailed in the provided data. The modification was authorized in 2003 and remains subject to FDA regulatory oversight.
Frequently asked questions
What is the Modification to HL168 device used for?
The Modification to HL168 is a cardiovascular device intended for use in diagnostic or monitoring procedures related to the heart. It represents a modified version of an existing device while maintaining its core functionality.
Is the Modification to HL168 a single-use or reusable device?
The Modification to HL168 is intended for both single-use and reusable applications in clinical settings, though specific details about sterility or reuse protocols are not provided in the available data.
What regulatory pathway was used for the Modification to HL168?
The device underwent a premarket notification review by the FDA under 510(k) clearance (K033043), classified as substantially equivalent with a special review pathway, and was authorized in 2003.
Who manufactures the Modification to HL168 device?
The Modification to HL168 is manufactured by Health & Life Co., Ltd., located in Chung Ho City, 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: K033043 - MODIFICATION TO HL168 | FDA 510 (k), Modification to Hl168 - Beudamed, Modification To Hl168 510 (k) FDA Premarket Notification K033043 HEALTH ..., MODIFICATION TO HL168 (K033043) — FDA 510 (k) | Innolitics, PDF K033043 MODIFICATION TO HL168 - 510kdatabase.net
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K033043 | Class II | Active |
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Manufacturer
- Manufacturer
- Health & Life Co., Ltd.
Sources (1)
- FDA 510(k) K033043 24 fields · synced Oct 6, 2026