GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)— 510(k) K160412

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K160412 for GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2), Substantially Equivalent on 2016-12-14. Applicant: Instrumentation Laboratory CO.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code CHL
Advisory panel: Clinical Chemistry
Date received: 2016-02-12
Decision date: 2016-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CHL

product code CHL

Death: 20
Malfunction: 999
Total: 1,019

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.