MODIFICATION TO ABL800 FLEX— 510(k) K050869

Name: FDA 510(k) clearance K050869
Creator: U.S. Food and Drug Administration
Published: 2005-08-11

Substantially Equivalent

Radiometer Medical Aps

FDA 510(k) clearance K050869 for MODIFICATION TO ABL800 FLEX, Substantially Equivalent on 2005-08-11. Applicant: Radiometer Medical Aps. Device class: 2.

Clearance details

Applicant: Radiometer Medical Aps
Product code: Code CIG
Device class: Class 2
Regulation: 21 CFR 862.1110
Advisory panel: Clinical Chemistry
Date received: 2005-04-06
Decision date: 2005-08-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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