NIRO-200NX DP— 510(k) K162117

Name: FDA 510(k) clearance K162117
Creator: U.S. Food and Drug Administration
Published: 2016-10-25

Substantially Equivalent

Hamamatsu Photonics K.K.

FDA 510(k) clearance K162117 for NIRO-200NX DP, Substantially Equivalent on 2016-10-25. Applicant: Hamamatsu Photonics K.K.. Device class: 2.

Clearance details

Applicant: Hamamatsu Photonics K.K.
Product code: Code MUD
Device class: Class 2
Regulation: 21 CFR 870.2700
Advisory panel: Cardiovascular
Date received: 2016-07-29
Decision date: 2016-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hamamatsu City, JP

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MUD

product code MUD

Malfunction: 467
Total: 467

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.