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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 the device name listed in this FDA 510(k) record. The listed applicant is Hamamatsu Photonics K.K.. It received FDA 510(k) clearance on 2016-10-25 under 510(k) 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. The listed applicant is Hamamatsu Photonics K.K.. The 510(k) number is K162117.

When did NIRO-200NX DP receive FDA 510(k) clearance?

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

Who is the listed applicant for NIRO-200NX DP?

The FDA 510(k) record lists Hamamatsu Photonics K.K. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Hamamatsu Photonics K.K. as applicant

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Official Source

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

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