FDA 510(k)

NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System

Número K: K182616 · 2018-11-02

Data da decisão2018-11-02

Código do produtoNQQ

Comité consultivoRA

DecisãoUnknown

Resumo do dispositivo

NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System is the device name listed in this FDA 510(k) record. The listed applicant is Ninepoint Medical, Inc.. It received FDA 510(k) clearance on 2018-11-02 under 510(k) number K182616. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Unknown.

Perguntas frequentes

What is the NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System?

NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System is a medical device that received FDA 510(k) clearance on 2018-11-02. The listed applicant is Ninepoint Medical, Inc.. The 510(k) number is K182616.

When did NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System receive FDA 510(k) clearance?

NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System received FDA 510(k) clearance on 2018-11-02, under 510(k) number K182616.

Who is the listed applicant for NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System?

The FDA 510(k) record lists Ninepoint Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System?

The FDA product code for NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System is NQQ.

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Outros registros que listam Ninepoint Medical, Inc. como candidato(a)

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