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FDA 510(k)

Libre Rio Continuous Glucose Monitoring System

K-Number: K233861 · 2024-06-07

ApplicantAbbott Diabetes Care
Decision Date2024-06-07
Product CodeSBH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Libre Rio Continuous Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Diabetes Care. It received FDA 510(k) clearance on 2024-06-07 under 510(k) number K233861. The device is classified under product code SBH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Libre Rio Continuous Glucose Monitoring System?

Libre Rio Continuous Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2024-06-07. The listed applicant is Abbott Diabetes Care. The 510(k) number is K233861.

When did Libre Rio Continuous Glucose Monitoring System receive FDA 510(k) clearance?

Libre Rio Continuous Glucose Monitoring System received FDA 510(k) clearance on 2024-06-07, under 510(k) number K233861.

Who is the listed applicant for Libre Rio Continuous Glucose Monitoring System?

The FDA 510(k) record lists Abbott Diabetes Care as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Libre Rio Continuous Glucose Monitoring System?

The FDA product code for Libre Rio Continuous Glucose Monitoring System is SBH.

Related Clinical Trials

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NCT05944432CGM Use in Adults With Type 2 Diabetes on Basal InsulinACTIVE_NOT_RECRUITINGNCT07739342Evaluating the Occurrence of DKA in People With Type I DiabetesNOT_YET_RECRUITINGNCT05676593Interest of FSL 2 in Recently Diagnosed Type 2 Diabetic PatientsTERMINATEDNCT05720377Evaluation of Exercise Application Technology in AdolescentsWITHDRAWNNCT06083038Utilizing Continuous Glucose Monitoring to Characterize and Manage Hyperglycemia in Patients Initiating AlpelisibCOMPLETEDNCT06310356Continuous Glucose Monitoring for Women With Gestational DiabetesRECRUITING

Other records listing Abbott Diabetes Care as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P160030Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiatedPMA P150021Sensor, glucose, invasiveK233537FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring SystemK223435FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring SystemK222447FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring SystemK223537FreeStyle Libre 2 System, FreeStyle Libre 3 System

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Related Devices (Code: SBH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262472Stelo Glucose Biosensor SystemDexcom, Inc.K260935Stelo Glucose Biosensor SystemDexcom, Inc.

Official Source

View on FDA Database →

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