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FDA 510(k)

Neteera 130H/131H Vital Sign Monitoring Sensor

K-Number: K212143 · 2022-09-28

ApplicantNeteera Technologies , Ltd.
Decision Date2022-09-28
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Neteera 130H/131H Vital Sign Monitoring Sensor is a medical device manufactured by Neteera Technologies , Ltd.. It received FDA 510(k) clearance on 2022-09-28 under approval number K212143. 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 Neteera 130H/131H Vital Sign Monitoring Sensor?

Neteera 130H/131H Vital Sign Monitoring Sensor is a medical device that received FDA 510(k) clearance on 2022-09-28. It is manufactured by Neteera Technologies , Ltd.. The 510(k) number is K212143.

When was Neteera 130H/131H Vital Sign Monitoring Sensor approved by the FDA?

Neteera 130H/131H Vital Sign Monitoring Sensor received FDA 510(k) clearance on 2022-09-28, under approval number K212143.

What company makes Neteera 130H/131H Vital Sign Monitoring Sensor?

Neteera 130H/131H Vital Sign Monitoring Sensor is manufactured by Neteera Technologies , Ltd..

What is the FDA product code for Neteera 130H/131H Vital Sign Monitoring Sensor?

The FDA product code for Neteera 130H/131H Vital Sign Monitoring Sensor is DRT.

Related Clinical Trials

NCT06682013 Virtual Agent Feasibility in Oncology Patients (NTT Data) WITHDRAWN NCT07611721 Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy. RECRUITING NCT06232876 Continuous Versus Intermittent Ward Monitoring NOT_YET_RECRUITING NCT06750549 Mobile Application for Patient Engagement and Physician-Directed Remote Management of Heart Failure COMPLETED NCT07595068 Low-Intensity Focused Ultrasound Targeting the Stellate Ganglion for Regulating Autonomic Nerve Function and Sleep Quality in Perioperative Patients With Cardiovascular Diseases NOT_YET_RECRUITING NCT07558291 Continuous Glucose Monitoring Versus Self-Monitoring of Blood Glucose in Women With Gestational Diabetes NOT_YET_RECRUITING

Related PubMed Literature

PMID: 40006408 Improving Fall Classification Accuracy of Multi-Input Models Using Three-Axis Accelerometer and Heart Rate Variability Data. Sensors (Basel, Switzerland) (2025)

Other Devices by Neteera Technologies , Ltd.

K231733Neteera 130H-Plus Vital Sign Monitoring Sensor

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. K181165Philips wearable biosensor-G5 SolutionConnected Sensing- A Division of Philips Medical Systems K202138Cardiac Trigger MonitorIvy Biomedical Systems, Inc. K202464Vital Sign Monitoring Sensor (Model :XK300)Xandar Kardian, Inc.

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.

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