NIRO-200NX— 510(k) K143219

Name: FDA 510(k) clearance K143219
Creator: U.S. Food and Drug Administration
Published: 2015-07-31

Substantially Equivalent

Hamamatsu Photonics K.K.

FDA 510(k) clearance K143219 for NIRO-200NX, Substantially Equivalent on 2015-07-31. 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: 2014-11-10
Decision date: 2015-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hamamatsu City, JP

Download summary PDF View on FDA.gov ↗

Recent devices under product code MUD

view all

K254129 — Spectrum-22026-05-22
K243324 — Masimo O3 Regional Oximeter2025-07-17
K250519 — Lap.Ox Laparoscopic Tissue Oximeter2025-06-26
K240596 — Cerebral Autoregulation Index (CAI) Algorithm2024-10-16
K241393 — ODI-Tech2024-08-30

More clearances from Hamamatsu Photonics K.K.

view all

K260964 — NanoZoomer S540MD Slide Scanner System2026-07-22
K253606 — NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system2026-07-15
K233027 — NanoZoomer S360MD Slide scanner system2023-12-22
K213883 — NanoZoomer S360MD Slide scanner system2022-09-27
K162117 — NIRO-200NX DP2016-10-25

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.