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FDA 510(k)

Compremium Compartment Compressibility Monitoring System (CPM#1)

K-Number: K223509 · 2023-04-14

ApplicantCompremium AG
Decision Date2023-04-14
Product CodeLXC
DecisionSubstantially Equivalent

Device Summary

Compremium Compartment Compressibility Monitoring System (CPM#1) is a medical device manufactured by Compremium AG. It received FDA 510(k) clearance on 2023-04-14 under approval number K223509. The device is classified under product code LXC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Compremium Compartment Compressibility Monitoring System (CPM#1)?

Compremium Compartment Compressibility Monitoring System (CPM#1) is a medical device that received FDA 510(k) clearance on 2023-04-14. It is manufactured by Compremium AG. The 510(k) number is K223509.

When was Compremium Compartment Compressibility Monitoring System (CPM#1) approved by the FDA?

Compremium Compartment Compressibility Monitoring System (CPM#1) received FDA 510(k) clearance on 2023-04-14, under approval number K223509.

What company makes Compremium Compartment Compressibility Monitoring System (CPM#1)?

Compremium Compartment Compressibility Monitoring System (CPM#1) is manufactured by Compremium AG.

What is the FDA product code for Compremium Compartment Compressibility Monitoring System (CPM#1)?

The FDA product code for Compremium Compartment Compressibility Monitoring System (CPM#1) is LXC.

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)

Related Devices (Code: LXC)

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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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