NeedleCam HD Visualization System

Arthroscope

BIOVISION TECHNOLOGIES, LLC

The following data is part of a premarket notification filed by Biovision Technologies, Llc with the FDA for Needlecam Hd Visualization System.

Pre-market Notification Details

Device IDK143705
510k NumberK143705
Device Name:NeedleCam HD Visualization System
ClassificationArthroscope
Applicant BIOVISION TECHNOLOGIES, LLC 221 CORPORATE CIRCLE UNIT H Golden,  CO  80401
ContactDavid Sanso
CorrespondentDavid Sanso
BIOVISION TECHNOLOGIES, LLC 221 CORPORATE CIRCLE UNIT H Golden,  CO  80401
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-12-29
Decision Date2015-02-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00851582006108 K143705 000
00851582006047 K143705 000

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