BIOPSY DIGIT-AM— 510(k) K062039

Substantially Equivalent

Giotto USA, LLC

FDA 510(k) clearance K062039 for BIOPSY DIGIT-AM, Substantially Equivalent on 2006-09-11. Applicant: Giotto USA, LLC. Device class: 2.

Clearance details

Applicant: Giotto USA, LLC
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 2006-07-19
Decision date: 2006-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carmel, IN, 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.