NVISION VLE IMAGING SYSTEM

System, Imaging, Optical Coherence Tomography (oct)

NINEPOINT MEDICAL, INC.

The following data is part of a premarket notification filed by Ninepoint Medical, Inc. with the FDA for Nvision Vle Imaging System.

Pre-market Notification Details

Device IDK120800
510k NumberK120800
Device Name:NVISION VLE IMAGING SYSTEM
ClassificationSystem, Imaging, Optical Coherence Tomography (oct)
Applicant NINEPOINT MEDICAL, INC. 1171 BARROILHET AVE Hillsborough,  CA  94010
ContactCindy Domecus, Rac (us & Eu)
CorrespondentCindy Domecus, Rac (us & Eu)
NINEPOINT MEDICAL, INC. 1171 BARROILHET AVE Hillsborough,  CA  94010
Product CodeNQQ  
CFR Regulation Number892.1560 [🔎]
DecisionSe - With Limitations (SESU)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-03-16
Decision Date2013-04-25
Summary:summary

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