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FDA 510(k)

Accuryn Monitoring System

K-Number: K153655 · 2016-04-15

ApplicantPotrero Medical, Inc.
Decision Date2016-04-15
Product CodeEZL
Advisory CommitteeGU
DecisionUnknown

Device Summary

Accuryn Monitoring System is a medical device manufactured by Potrero Medical, Inc.. It received FDA 510(k) clearance on 2016-04-15 under approval number K153655. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the Accuryn Monitoring System?

Accuryn Monitoring System is a medical device that received FDA 510(k) clearance on 2016-04-15. It is manufactured by Potrero Medical, Inc.. The 510(k) number is K153655.

When was Accuryn Monitoring System approved by the FDA?

Accuryn Monitoring System received FDA 510(k) clearance on 2016-04-15, under approval number K153655.

What company makes Accuryn Monitoring System?

Accuryn Monitoring System is manufactured by Potrero Medical, Inc..

What is the FDA product code for Accuryn Monitoring System?

The FDA product code for Accuryn Monitoring System is EZL.

Related Clinical Trials

NCT07092761 Evaluation of the Accuracy and Safety of A Novel Real-Time Continuous Glucose Monitoring System RECRUITING NCT07499128 Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event ENROLLING_BY_INVITATION NCT07614581 Intra-Sessional Autonomic Arc Detection in Ketamine-Assisted Therapy for PTSD: A Signal Characterisation Pilot Study NOT_YET_RECRUITING NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED 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 NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING

Related PubMed Literature

PMID: 37181834 Methodology for Conducting Post-Marketing Surveillance of Software as a Medical Device Based on Artificial Intelligence Technologies. Sovremennye tekhnologii v meditsine (2022)

Other Devices by Potrero Medical, Inc.

K221020Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F

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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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