RADIANALYZER, MODEL 12710— 510(k) K002067

Name: FDA 510(k) clearance K002067
Creator: U.S. Food and Drug Administration
Published: 2001-01-11

Substantially Equivalent

Radi Medical Systems AB

FDA 510(k) clearance K002067 for RADIANALYZER, MODEL 12710, Substantially Equivalent on 2001-01-11. Applicant: Radi Medical Systems AB. Device class: 2.

Clearance details

Applicant: Radi Medical Systems AB
Product code: Code DSK
Device class: Class 2
Regulation: 21 CFR 870.1110
Advisory panel: Cardiovascular
Date received: 2000-07-07
Decision date: 2001-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Uppsala, SE

Download summary PDF View on FDA.gov ↗

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