FDA 510(k) · Verily Life Sciences
K213357: Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor (Verily Life Sciences, LLC)
Verily Life Sciences, LLC received FDA 510(k) K213357 for Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor, with a decision date of Jul 19, 2022 (substantially equivalent).
Prescription or OTC: Prescription (Rx) parsed from FDA documents (summary PDF: indications text (parsed))
FDA facts
| FDA number | K213357 |
|---|---|
| Pathway | 510(k) |
| Applicant | Verily Life Sciences, LLC |
| Device name | Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor |
| Product code | DXH: Transmitters And Receivers, Electrocardiograph, Telephone |
| Regulation (21 CFR) | 870.2920 |
| Device class | Class 2 |
| Date received | Oct 12, 2021 |
| Decision date | Jul 19, 2022 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
The Study Watch with Irregular Pulse Monitor is indicated for use by adult patients (22 years and older) who have been diagnosed with, or are susceptible to developing, atrial fibrillation enabling them to monitor and record their heart rhythms. Study Watch is also intended to record, store, transfer, and display single-channel electrocardiogram (ECG) rhythms. The Study Watch with Irregular Pulse Monitor is intended for prescription use only. K213357
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
- K192415 Study Watch with Irregular Pulse Monitor (Verily Life Sciences)
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code DXH is "Transmitters And Receivers, Electrocardiograph, Telephone", class 2, 21 CFR 870.2920.
Our labels for filtering: claim ECG, sensor Wrist PPG. These are heuristics, not FDA fields.