BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM

Ophthalmoscope, Ac-powered

BIOPTIGEN, INC.

The following data is part of a premarket notification filed by Bioptigen, Inc. with the FDA for Bioptigen Spectral Domain Ophthalmic Imaging System.

Pre-market Notification Details

Device IDK063343
510k NumberK063343
Device Name:BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM
ClassificationOphthalmoscope, Ac-powered
Applicant BIOPTIGEN, INC. 719 A ST. NE Washington,  DC  20002
ContactRussell Pagano
CorrespondentJeffrey D Rongero
UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle,  NC  27709
Product CodeHLI  
CFR Regulation Number886.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2006-11-06
Decision Date2006-12-13
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.