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FDA 510(k)

Nova StatSensor Creatinine Hospital Meter System

K-Number: K171059 · 2017-05-26

ApplicantNova Biomedical Corporation
Decision Date2017-05-26
Product CodeCGL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Nova StatSensor Creatinine Hospital Meter System is a medical device manufactured by Nova Biomedical Corporation. It received FDA 510(k) clearance on 2017-05-26 under approval number K171059. The device is classified under product code CGL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nova StatSensor Creatinine Hospital Meter System?

Nova StatSensor Creatinine Hospital Meter System is a medical device that received FDA 510(k) clearance on 2017-05-26. It is manufactured by Nova Biomedical Corporation. The 510(k) number is K171059.

When was Nova StatSensor Creatinine Hospital Meter System approved by the FDA?

Nova StatSensor Creatinine Hospital Meter System received FDA 510(k) clearance on 2017-05-26, under approval number K171059.

What company makes Nova StatSensor Creatinine Hospital Meter System?

Nova StatSensor Creatinine Hospital Meter System is manufactured by Nova Biomedical Corporation.

What is the FDA product code for Nova StatSensor Creatinine Hospital Meter System?

The FDA product code for Nova StatSensor Creatinine Hospital Meter System is CGL.

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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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