Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BioVision Plus

K-Number: K153583 · 2016-04-01

ApplicantFaxitron Bioptics, LLC
Decision Date2016-04-01
Product CodeMWP
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BioVision Plus is a medical device manufactured by Faxitron Bioptics, LLC. It received FDA 510(k) clearance on 2016-04-01 under approval number K153583. The device is classified under product code MWP. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BioVision Plus?

BioVision Plus is a medical device that received FDA 510(k) clearance on 2016-04-01. It is manufactured by Faxitron Bioptics, LLC. The 510(k) number is K153583.

When was BioVision Plus approved by the FDA?

BioVision Plus received FDA 510(k) clearance on 2016-04-01, under approval number K153583.

What company makes BioVision Plus?

BioVision Plus is manufactured by Faxitron Bioptics, LLC.

What is the FDA product code for BioVision Plus?

The FDA product code for BioVision Plus is MWP.

Other Devices by Faxitron Bioptics, LLC

K170786Faxitron Bioptics Speciemen Radiography System K173309Faxitron VisionCT K183142PathVisionXL

Related Devices (Code: MWP)

K170786Faxitron Bioptics Speciemen Radiography SystemFaxitron Bioptics, LLC K173309Faxitron VisionCTFaxitron Bioptics, LLC K192939Volumetric Specimen ImagerClarix Imaging K193317CoreLite X-Ray Specimen CabinetCirdan Imaging Limited K183624Kubtec Mozart (Xpert42)Kub Technologies, Inc. K183142PathVisionXLFaxitron Bioptics, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑