FDA 510(k) · Verily Life Sciences
K182456: Study Watch (Verily Life Sciences, LLC)
Verily Life Sciences, LLC received FDA 510(k) K182456 for Study Watch, with a decision date of Jan 17, 2019 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K182456 |
|---|---|
| Pathway | 510(k) |
| Applicant | Verily Life Sciences, LLC |
| Device name | Study Watch |
| Product code | DXH: Transmitters And Receivers, Electrocardiograph, Telephone |
| Regulation (21 CFR) | 870.2920 |
| Device class | Class 2 |
| Date received | Sep 7, 2018 |
| Decision date | Jan 17, 2019 |
| 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 is intended to record, store, transfer, and display single-channel electrocardiogram (ECG) rhythms. The Study Watch is intended for use by healthcare professionals, adult patients (22 years or older) with known or suspected heart conditions, and health conscious individuals.
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
No predicate numbers were parsed for this record. The FDA summary, if available, names the predicate.
Later records that cite K182456
- K192415 Study Watch with Irregular Pulse Monitor (Verily Life Sciences, Jan 17, 2020, DXH)
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.