Nihon Kohden Afib Detection Program QP-039P
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K152305 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 Nihon Kohden Afib Detection Program Qp-039p is a Detector And Alarm, Arrhythmia device used for processing adult patient data to detect atrial fibrillation (AF) if present continuously for more than 2.5 minutes. It is intended to be used by qualified health care professionals in a hospital or clinical environment.
The device is supplied as software and is classified as a Class 2 device under regulation 870.1025. It has been cleared by the FDA under the abbreviated clearance type with the decision code SESE. The device is intended for use in the Cardiovascular medical specialty and has the product code DSI.
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: Nihon Kohden Afib Detection Program QP-039P (K152305 ... - fda ..., PDF Nihon Kohden Afib Detection Program QP-039P 510(k) K152305 - fda.report, K152305 - Nihon Kohden Afib Detection Program QP-039P
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K152305 | Class II | Active |
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Manufacturer
- Manufacturer
- Nihon Kohden Corporation
Sources (1)
- FDA 510(k) K152305 24 fields · synced Oct 6, 2026