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FDA 510(k)

QUANTIEN Measurement System

K-Number: K183099 · 2019-02-28

ApplicantSt. Jude Medical (Now Abbott Medical)
Decision Date2019-02-28
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

QUANTIEN Measurement System is a medical device manufactured by St. Jude Medical (Now Abbott Medical). It received FDA 510(k) clearance on 2019-02-28 under approval number K183099. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTIEN Measurement System?

QUANTIEN Measurement System is a medical device that received FDA 510(k) clearance on 2019-02-28. It is manufactured by St. Jude Medical (Now Abbott Medical). The 510(k) number is K183099.

When was QUANTIEN Measurement System approved by the FDA?

QUANTIEN Measurement System received FDA 510(k) clearance on 2019-02-28, under approval number K183099.

What company makes QUANTIEN Measurement System?

QUANTIEN Measurement System is manufactured by St. Jude Medical (Now Abbott Medical).

What is the FDA product code for QUANTIEN Measurement System?

The FDA product code for QUANTIEN Measurement System is DQK.

Related Clinical Trials

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Related PubMed Literature

PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025)

Other Devices by St. Jude Medical (Now Abbott Medical)

K183320Ilumien Optis, Optis Integrated, Optis Mobile

Related Devices (Code: DQK)

K160218AutoMark ModuleSt Jude Medical K160210EnSite Precision Cardiac Mapping System v2.0St Jude Medical K162643MediGuide Technology SystemSt Jude Medical K162440CardioInsight Cardiac Mapping SystemCardioinsight Technologies, Inc. K160187Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0St Jude Medical K160186EnSite Velocity Surface Electrode KitSt Jude Medical

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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