OPTISTRAND, MODEL 1032S— 510(k) K043336

Substantially Equivalent

Ibt SA

FDA 510(k) clearance K043336 for OPTISTRAND, MODEL 1032S, Substantially Equivalent on 2005-01-21. Applicant: Ibt SA. Device class: 2.

Clearance details

Applicant: Ibt SA
Product code: Code KXK
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 2004-12-03
Decision date: 2005-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

Download summary PDF View on FDA.gov ↗

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