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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 the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 2016-12-14 under 510(k) 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. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K160412.

When did GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2) receive FDA 510(k) clearance?

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

Who is the listed applicant for GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)?

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

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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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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