FDA.reportPublic FDA data

510(k) K223608

Device
GEM Premier 7000 with IQM3
Applicant
Instrumentation Laboratory Company
510(k) number
K223608
Product code
CHL
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-10
Date received
2022-12-02
Regulation
862.1120
Classification name
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Gabriella Erdosy
Address
180 Hartwell Rd. Bedford MA US 01730 01730

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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