ABL90 FLEX, ABL90 FLEX PLUS— 510(k) K170882

Name: FDA 510(k) clearance K170882
Creator: U.S. Food and Drug Administration
Published: 2017-04-28

Substantially Equivalent

Radiometer Medical Aps

FDA 510(k) clearance K170882 for ABL90 FLEX, ABL90 FLEX PLUS, Substantially Equivalent on 2017-04-28. Applicant: Radiometer Medical Aps. Device class: 1.

Clearance details

Applicant: Radiometer Medical Aps
Product code: Code MQM
Device class: Class 1
Regulation: 21 CFR 862.1113
Advisory panel: Clinical Chemistry
Date received: 2017-03-24
Decision date: 2017-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Broenshoej, DK

Download summary PDF View on FDA.gov ↗

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