Study Watch with Irregular Pulse Monitor
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K192415 FDA 510(k)
- FDA Product Code
- DXH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2920 FDA 510(k)
- Regulation Number
- 870.2920 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Study Watch with Irregular Pulse Monitor is a telephone electrocardiograph transmitter and receiver. It is indicated for use by adult patients 22 years and older who have been diagnosed with, or are susceptible to developing, atrial fibrillation to monitor and record their heart rhythm.
This device is regulated as a Class II medical device under FDA 510(k) clearance. It is intended for use by patients in a home setting.
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: Study Watch with Irregular Pulse Monitor (Home), Study Watch with ..., Study Watch with Irregular Pulse Monitor (K192415) — FDA 510(k ..., Study Watch with Irregular Pulse Monitor (Home), Study Watch with ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192415 | Class II | Active |
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Manufacturer
- Manufacturer
- Verily Life Sciences, LLC
Sources (1)
- FDA 510(k) K192415 24 fields · synced Sep 22, 2026