COLLIMATOR, MODEL M-38— 510(k) K062788

Substantially Equivalent

Umi International

FDA 510(k) clearance K062788 for COLLIMATOR, MODEL M-38, Substantially Equivalent on 2006-12-28. Applicant: Umi International. Device class: 2.

Clearance details

Applicant: Umi International
Product code: Code KPW
Device class: Class 2
Regulation: 21 CFR 892.1610
Advisory panel: Radiology
Date received: 2006-09-18
Decision date: 2006-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwood, NJ, 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.