BioVision Plus— 510(k) K153583

Substantially Equivalent

Faxitron Bioptics, LLC

FDA 510(k) clearance K153583 for BioVision Plus, Substantially Equivalent on 2016-04-01. Applicant: Faxitron Bioptics, LLC. Device class: 2.

Clearance details

Applicant: Faxitron Bioptics, LLC
Product code: Code MWP
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2015-12-15
Decision date: 2016-04-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Tucson, AZ, 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.