Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Study Watch

K-Number: K182456 · 2019-01-17

ApplicantVerily Life Sciences, LLC
Decision Date2019-01-17
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Study Watch is a medical device manufactured by Verily Life Sciences, LLC. It received FDA 510(k) clearance on 2019-01-17 under approval number K182456. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Study Watch?

Study Watch is a medical device that received FDA 510(k) clearance on 2019-01-17. It is manufactured by Verily Life Sciences, LLC. The 510(k) number is K182456.

When was Study Watch approved by the FDA?

Study Watch received FDA 510(k) clearance on 2019-01-17, under approval number K182456.

What company makes Study Watch?

Study Watch is manufactured by Verily Life Sciences, LLC.

What is the FDA product code for Study Watch?

The FDA product code for Study Watch is DXH. This falls under the Hematology category.

Related Clinical Trials

NCT07143838 Enhancing Slow Wave Sleep in Depression NOT_YET_RECRUITING NCT07339020 Cyanoacrylate Versus Omentum for Staple-Line Reinforcement in Sleeve Gastrectomy COMPLETED NCT06668402 Study of Daily Step Count and Treatment Response in Rectal Cancer (STEP-R) COMPLETED NCT05457166 Use of the KASPARD System for Fall Prevention in Nursing Homes COMPLETED NCT07568860 Sleep-Driven Adaptive Neuromodulation in Lennox-Gastaut Syndrome NOT_YET_RECRUITING NCT06938672 Evaluating the Effects of tDCS on Sleep and Cognition in Healthy Older Adults COMPLETED

Related PubMed Literature

PMID: 41029804 Identifying common patterns in journals that retracted papers from paper mills: a cross-sectional study. Research integrity and peer review (2025)

Other Devices by Verily Life Sciences, LLC

K192415Study Watch with Irregular Pulse Monitor K213357Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor K242508Verily Numetric Retinal Camera

Related Devices (Code: DXH)

K161431SimplECGNanowear, Inc. K172311BioFlux DeviceBiotricity, Inc. K171816Kardia Band SystemAliveCor, Inc. K172801ECG SENTINEL SystemCardiomedix, Inc. K170506ECG Check - Universal, ECG Check - Universal PlusCardiac Designs, Inc. K170181PrizmaG-Medical Innovations , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑