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FDA 510(k)

GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)

K-Number: K160412 · 2016-12-14

ApplicantInstrumentation Laboratory CO
Decision Date2016-12-14
Product CodeCHL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2) is a medical device manufactured by Instrumentation Laboratory CO. It received FDA 510(k) clearance on 2016-12-14 under approval number K160412. The device is classified under product code CHL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)?

GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2) 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 K160412.

When was GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2) approved by the FDA?

GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2) received FDA 510(k) clearance on 2016-12-14, under approval number K160412.

What company makes GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)?

GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2) is manufactured by Instrumentation Laboratory CO.

What is the FDA product code for GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)?

The FDA product code for GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2) is CHL.

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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 K160415GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation) K160402GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) K160885HemosIL D-Dimer HS K161818GEM Premier 3000 K153137HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls

View all 26 devices →

Related Devices (Code: CHL)

K160153ABL90 FLEX PLUSRadiometer Medical Aps K151978EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit ControlEdan Instruments, Inc. K173403GEM Premier 5000Instrumentation Laboratory CO K173797Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation K200107epoc Blood Analysis SystemEpocal, Inc. K200492i-STAT CG4+ Cartridge with the i-STAT 1 SystemAbbott Point of Care, 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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