Study Watch

FDA 510(k) K182456 · Verily Life Sciences, LLC

Substantially Equivalent

510(k) numberK182456

Submission

Device name
Study Watch
Applicant
Verily Life Sciences, LLC
South San Francisco, CA, US
Received
September 7, 2018
Decision date
January 17, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DXH – Transmitters And Receivers, Electrocardiograph, Telephone
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2920
Specialty
Cardiovascular

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K243438MEMO Patch M (MPT-E08R-UNC01)DXH · Traditional Huinno Co., Ltd.12/05/2025SE
K243981Hexoskin Medical System (7100-00016)DXH · Traditional Carre Technologies, Inc.11/18/2025SE
K243003VitalSigns 1-Lead Holter (VSH101)DXH · Traditional VitalSigns Technology Co., Ltd.06/17/2025SE
K233521QT ECG (QTERD100)DXH · Special QT Medical, Inc.12/06/2023SE
K222842V-Patch Cardiac MonitorDXH · Traditional Shandong Corecare Technology Limited10/20/2022SE
K220795QT ECGDXH · Traditional QT Medical, Inc.09/26/2022SE
K213357Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse MonitorDXH · Traditional Verily Life Sciences, LLC07/19/2022SE
K220350KardiaMobile 6LDXH · Traditional AliveCor, Inc.05/25/2022SE

More from AliveCor, Inc.

510(k)DeviceDecision
K242508Verily Numetric Retinal CameraHKI · Traditional 12/09/2024SE
K213357Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse MonitorDXH · Traditional 07/19/2022SE
K192415Study Watch with Irregular Pulse MonitorDXH · Traditional 01/17/2020SE

Questions and answers

When was Study Watch cleared by the FDA?

Study Watch (K182456) received a 510(k) decision of Substantially Equivalent on January 17, 2019, 132 days after the submission was received.

What is the product code of K182456?

The FDA product code is DXH – Transmitters And Receivers, Electrocardiograph, Telephone, a Class II (moderate risk) device regulated under 21 CFR 870.2920.