Fukuda Denshi DS-1020A & DS-1040A Dynascopy Series
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K850897 FDA 510(k)
- FDA Product Code
- DSI 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 Fukuda Denshi DS-1020A & DS-1040A Dynascopy Series is a cardiovascular device designed for detecting and monitoring arrhythmias. It functions as a detector and alarm system to identify irregular heart rhythms.
This device is supplied by Fukuda Denshi USA, Inc. and is classified as a Class II medical device. It is authorized under FDA 510K clearance with the product code DSI and is intended for cardiovascular use.
Frequently asked questions
What is the Fukuda Denshi DS-1020A & DS-1040A Dynascopy Series used for?
The Fukuda Denshi DS-1020A & DS-1040A Dynascopy Series is a cardiovascular device designed specifically for detecting and monitoring arrhythmias. It functions as a detector and alarm system to identify irregular heart rhythms in patients.
How is the Fukuda Denshi DS-1020A & DS-1040A Dynascopy Series supplied?
The device is supplied by Fukuda Denshi USA, Inc. It is classified as a Class II medical device and is intended for cardiovascular use in clinical settings where arrhythmia detection is required.
What is the regulatory status of the Fukuda Denshi DS-1020A & DS-1040A Dynascopy Series?
The Fukuda Denshi DS-1020A & DS-1040A Dynascopy Series is authorized under FDA 510K clearance with the product code DSI. It has been determined to be substantially equivalent to other devices in its class for cardiovascular use.
Can the Fukuda Denshi DS-1020A & DS-1040A Dynascopy Series be reused or is it single-use?
The device data does not specify whether the Fukuda Denshi DS-1020A & DS-1040A Dynascopy Series is designed for single-use or multiple uses. This information would need to be obtained directly from the manufacturer or product documentation.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K850897 | Class II | Active |
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Manufacturer
- Manufacturer
- Fukuda Denshi Usa, Inc.
Sources (1)
- FDA 510(k) K850897 24 fields · synced Sep 21, 2026