Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NIRO-200NX DP

K-Number: K162117 · 2016-10-25

ApplicantHamamatsu Photonics K.K.
Decision Date2016-10-25
Product CodeMUD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NIRO-200NX DP is a medical device manufactured by Hamamatsu Photonics K.K.. It received FDA 510(k) clearance on 2016-10-25 under approval number K162117. The device is classified under product code MUD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIRO-200NX DP?

NIRO-200NX DP is a medical device that received FDA 510(k) clearance on 2016-10-25. It is manufactured by Hamamatsu Photonics K.K.. The 510(k) number is K162117.

When was NIRO-200NX DP approved by the FDA?

NIRO-200NX DP received FDA 510(k) clearance on 2016-10-25, under approval number K162117.

What company makes NIRO-200NX DP?

NIRO-200NX DP is manufactured by Hamamatsu Photonics K.K..

What is the FDA product code for NIRO-200NX DP?

The FDA product code for NIRO-200NX DP is MUD.

Other Devices by Hamamatsu Photonics K.K.

K213883NanoZoomer S360MD Slide scanner system K233027NanoZoomer S360MD Slide scanner system

Related Devices (Code: MUD)

K153426Ox-Imager CSModulated Imaging, Inc. K161237HyperView Hyperspectral Tissue Oxygenation Measurement SystemHypermed Imaging, Inc. K160526Masimo O3 Regional Oximeter SystemMasimo Corporation K163472Intra.Ox Handheld Tissue OximeterVioptix, Inc. K162603Masimo O3 Regional Oximeter SystemMasimo Corporation K163070Kent CameraKent 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.

↑