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FDA 510(k)

NvisionVLE Low-profile Optical Probe

K-Number: K191117 · 2019-07-19

ApplicantNinepoint Medical, Inc.
Decision Date2019-07-19
Product CodeNQQ
Advisory CommitteeRA
DecisionUnknown

Device Summary

NvisionVLE Low-profile Optical Probe is a medical device manufactured by Ninepoint Medical, Inc.. It received FDA 510(k) clearance on 2019-07-19 under approval number K191117. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the NvisionVLE Low-profile Optical Probe?

NvisionVLE Low-profile Optical Probe is a medical device that received FDA 510(k) clearance on 2019-07-19. It is manufactured by Ninepoint Medical, Inc.. The 510(k) number is K191117.

When was NvisionVLE Low-profile Optical Probe approved by the FDA?

NvisionVLE Low-profile Optical Probe received FDA 510(k) clearance on 2019-07-19, under approval number K191117.

What company makes NvisionVLE Low-profile Optical Probe?

NvisionVLE Low-profile Optical Probe is manufactured by Ninepoint Medical, Inc..

What is the FDA product code for NvisionVLE Low-profile Optical Probe?

The FDA product code for NvisionVLE Low-profile Optical Probe is NQQ.

Related Clinical Trials

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Other Devices by Ninepoint Medical, Inc.

K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System K182261NvisionVLE Imaging System, NvisionVLE Optical Probe

Related Devices (Code: NQQ)

K162466LuminScan (TM) Imaging SystemMicro-Tech (Nanjing) Co., Ltd. K153283VivoSight Dx Topical OCT SystemMichelson Diagnostics, Ltd. K160878OPTIS Metallic Stent Optimization E.4 SWLightlab Imaging, Inc. K160240Perimeter Otis™ 1.0 Optical Coherence Tomography SystemPerimeter Medical Imaging, Inc. K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation SystemNinepoint Medical, Inc. K171560OTIS Optical Coherence Tomography SystemPerimeter Medical Imaging, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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