EnFocus 2300, EnFocus 4400

Tomography, Optical Coherence

Bioptigen, Inc.

The following data is part of a premarket notification filed by Bioptigen, Inc. with the FDA for Enfocus 2300, Enfocus 4400.

Pre-market Notification Details

Device IDK162783
510k NumberK162783
Device Name:EnFocus 2300, EnFocus 4400
ClassificationTomography, Optical Coherence
Applicant Bioptigen, Inc. 633 Davis Drive Morrisville,  NC  27560
ContactRavi Kommineni
CorrespondentRavi Kommineni
Bioptigen, Inc. 633 Davis Drive Morrisville,  NC  27560
Product CodeOBO  
CFR Regulation Number886.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-10-03
Decision Date2016-12-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00857691006039 K162783 000

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