EXTEND FRAME SYSTEM, MODEL 1009633— 510(k) K092083

Name: FDA 510(k) clearance K092083
Creator: U.S. Food and Drug Administration
Published: 2009-09-22

Substantially Equivalent

Elekta Instrument AB

FDA 510(k) clearance K092083 for EXTEND FRAME SYSTEM, MODEL 1009633, Substantially Equivalent on 2009-09-22. Applicant: Elekta Instrument AB. Device class: 2.

Clearance details

Applicant: Elekta Instrument AB
Product code: Code IWB
Device class: Class 2
Regulation: 21 CFR 892.5750
Advisory panel: Radiology
Date received: 2009-07-09
Decision date: 2009-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stockholm, SE

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.