RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720— 510(k) K013943

Name: FDA 510(k) clearance K013943
Creator: U.S. Food and Drug Administration
Published: 2001-12-18

Substantially Equivalent

Radi Medical Systems AB

FDA 510(k) clearance K013943 for RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720, Substantially Equivalent on 2001-12-18. 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: 2001-11-29
Decision date: 2001-12-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Uppsala, SE

Download summary PDF View on FDA.gov ↗

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