NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory

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 Nvisionvle Imaging System, Nvisionvle Optical Probe, Nvisionvle Inflation Accessory.

Pre-market Notification Details

Device IDK143678
510k NumberK143678
Device Name:NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory
ClassificationSystem, Imaging, Optical Coherence Tomography (oct)
Applicant NINEPOINT MEDICAL, INC. ONE KENDALL SQUARE, SUITE B7501 Cambridge,  MA  02139
ContactScott Blood
CorrespondentScott Blood
NINEPOINT MEDICAL, INC. ONE KENDALL SQUARE, SUITE B7501 Cambridge,  MA  02139
Product CodeNQQ  
CFR Regulation Number892.1560 [🔎]
DecisionSe - With Limitations (SESU)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-12-24
Decision Date2015-02-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00859591006232 K143678 000
00859591006034 K143678 000
00859591006041 K143678 000
00859591006089 K143678 000
00859591006096 K143678 000
00859591006157 K143678 000
00859591006164 K143678 000
00859591006171 K143678 000
00859591006188 K143678 000
00859591006195 K143678 000
00859591006201 K143678 000
00859591006027 K143678 000

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