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FDA 510(k)

GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)

K-Number: K160415 · 2016-12-14

ApplicantInstrumentation Laboratory CO
Decision Date2016-12-14
Product CodeGKF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation) is a medical device manufactured by Instrumentation Laboratory CO. It received FDA 510(k) clearance on 2016-12-14 under approval number K160415. The device is classified under product code GKF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)?

GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation) is a medical device that received FDA 510(k) clearance on 2016-12-14. It is manufactured by Instrumentation Laboratory CO. The 510(k) number is K160415.

When was GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation) approved by the FDA?

GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation) received FDA 510(k) clearance on 2016-12-14, under approval number K160415.

What company makes GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)?

GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation) is manufactured by Instrumentation Laboratory CO.

What is the FDA product code for GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)?

The FDA product code for GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation) is GKF.

Related Clinical Trials

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Related PubMed Literature

PMID: 25313967 The accuracy of a near-infrared spectroscopy cerebral oximetry device and its potential value for estimating jugular venous oxygen saturation. Anesthesia and analgesia (2014)

Other Devices by Instrumentation Laboratory CO

K160225GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator K160402GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) K160412GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2) K160885HemosIL D-Dimer HS K161818GEM Premier 3000 K153137HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls

View all 26 devices →

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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