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)

Philips wearable biosensor-G5 Solution

K-Number: K181165 · 2019-03-07

ApplicantConnected Sensing- A Division of Philips Medical Systems
Decision Date2019-03-07
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Philips wearable biosensor-G5 Solution is a medical device manufactured by Connected Sensing- A Division of Philips Medical Systems. It received FDA 510(k) clearance on 2019-03-07 under approval number K181165. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Philips wearable biosensor-G5 Solution?

Philips wearable biosensor-G5 Solution is a medical device that received FDA 510(k) clearance on 2019-03-07. It is manufactured by Connected Sensing- A Division of Philips Medical Systems. The 510(k) number is K181165.

When was Philips wearable biosensor-G5 Solution approved by the FDA?

Philips wearable biosensor-G5 Solution received FDA 510(k) clearance on 2019-03-07, under approval number K181165.

What company makes Philips wearable biosensor-G5 Solution?

Philips wearable biosensor-G5 Solution is manufactured by Connected Sensing- A Division of Philips Medical Systems.

What is the FDA product code for Philips wearable biosensor-G5 Solution?

The FDA product code for Philips wearable biosensor-G5 Solution is DRT.

Related Clinical Trials

NCT07614581 Intra-Sessional Autonomic Arc Detection in Ketamine-Assisted Therapy for PTSD: A Signal Characterisation Pilot Study NOT_YET_RECRUITING NCT07612085 A Wearable Biosensor Patch for Non-Invasive Monitoring for Patients Undergoing Abdominal or Chest Surgery NOT_YET_RECRUITING NCT07558122 Malaria CVD 36000; Gates INV090205 NOT_YET_RECRUITING NCT06292299 The PARS Study: Paediatric Advanced Respiratory Service Study - An Observational Diagnostic Feasibility Study RECRUITING

Related PubMed Literature

PMID: 41625077 Multianalyte nano-biosensor diagnostics: advances through microfluidic and AI integration. Frontiers in bioengineering and biotechnology (2025)

Related Devices (Code: DRT)

K151781Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization MonitorIvy Biomedical Systems, Inc. K170828Cardiac Trigger MonitorIvy Biomedical Systems, Inc. K172586Vios Monitoring System™ Model 2050Vios Medical, Inc. K202138Cardiac Trigger MonitorIvy Biomedical Systems, Inc. K202464Vital Sign Monitoring Sensor (Model :XK300)Xandar Kardian, Inc. K212143Neteera 130H/131H Vital Sign Monitoring SensorNeteera Technologies , 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.

↑