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FDA 510(k)

Lingo Glucose System

K-Number: K233655 · 2024-05-29

ApplicantAbbott
Decision Date2024-05-29
Product CodeSAF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Lingo Glucose System is the device name listed in this FDA 510(k) record. The listed applicant is Abbott. It received FDA 510(k) clearance on 2024-05-29 under 510(k) number K233655. The device is classified under product code SAF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lingo Glucose System?

Lingo Glucose System is a medical device that received FDA 510(k) clearance on 2024-05-29. The listed applicant is Abbott. The 510(k) number is K233655.

When did Lingo Glucose System receive FDA 510(k) clearance?

Lingo Glucose System received FDA 510(k) clearance on 2024-05-29, under 510(k) number K233655.

Who is the listed applicant for Lingo Glucose System?

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

What is the FDA product code for Lingo Glucose System?

The FDA product code for Lingo Glucose System is SAF.

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Related Devices (Code: SAF)

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.

K261359Stelo Glucose Biosensor SystemDexcom, Inc.K250106Signos Glucose Monitoring SystemSignos, Inc.K234070Stelo Glucose Biosensor SystemDexcom, 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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