Study Watch with Irregular Pulse Monitor— 510(k) K192415

Name: FDA 510(k) clearance K192415
Creator: U.S. Food and Drug Administration
Published: 2020-01-17

Substantially Equivalent

Verily Life Sciences, LLC

FDA 510(k) clearance K192415 for Study Watch with Irregular Pulse Monitor, Substantially Equivalent on 2020-01-17. Applicant: Verily Life Sciences, LLC. Device class: 2.

Clearance details

Applicant: Verily Life Sciences, LLC
Product code: Code DXH
Device class: Class 2
Regulation: 21 CFR 870.2920
Advisory panel: Cardiovascular
Date received: 2019-09-04
Decision date: 2020-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DXH

view all

K250233 — PreemptiveAI Clinical SDK2026-02-13
K250258 — HeartBeam AIMIGo with 12-L ECG Synthesis Software System2025-12-08
K243438 — MEMO Patch M (MPT-E08R-UNC01)2025-12-05
K243981 — Hexoskin Medical System (7100-00016)2025-11-18
K243003 — VitalSigns 1-Lead Holter (VSH101)2025-06-17

More clearances from Verily Life Sciences, LLC

view all

K242508 — Verily Numetric Retinal Camera2024-12-09
K213357 — Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor2022-07-19
K182456 — Study Watch2019-01-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.