NIRO-200NX
FDA 510(k) K143219 · Hamamatsu Photonics K.K.
510(k) numberK143219
Submission
- Device name
- NIRO-200NX
- Applicant
- Hamamatsu Photonics K.K.
Hamamatsu City, JP - Received
- November 10, 2014
- Decision date
- July 31, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MUD – Oximeter, Tissue Saturation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2700
- Specialty
- Cardiovascular
Other 510(k)s with product code MUD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254129 | Spectrum-2MUD · Traditional | Neko Health AB | 05/22/2026SE |
| K243324 | Masimo O3 Regional OximeterMUD · Traditional | Masimo Corporation | 07/17/2025SE |
| K250519 | Lap.Ox Laparoscopic Tissue OximeterMUD · Traditional | ViOptix, Inc. | 06/26/2025SE |
| K240596 | Cerebral Autoregulation Index (CAI) AlgorithmMUD · Traditional | Edwards Lifesciences | 10/16/2024SE |
| K241393 | ODI-TechMUD · Traditional | Odi Medical AS | 08/30/2024SE |
| K240601 | SnapshotNIR model KD205MUD · Traditional | Kent Imaging, Inc. | 04/02/2024SE |
| K232385 | OxiplexTS200MUD · Traditional | Iss Medical, Inc. | 03/01/2024SE |
| K233488 | Intra.Ox 2.0 Handheld Tissue OximeterMUD · Traditional | Vioptix, Inc. | 02/28/2024SE |
| K230612 | Edwards Algorithm for Measurement of Blood HemoglobinMUD · Traditional | Edwards Lifesciences, LLC | 11/17/2023SE |
| K223651 | Cerebral Adaptive Index (CAI) AlgorithmMUD · Traditional | Edwards Lifesciences, LLC | 05/26/2023SE |
More from Edwards Lifesciences, LLC
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| K260964 | NanoZoomer S540MD Slide Scanner SystemPSY · Abbreviated | 07/22/2026SE |
| K253606 | NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner systemPSY · Abbreviated | 07/15/2026SE |
| K233027 | NanoZoomer S360MD Slide scanner systemPSY · Abbreviated | 12/22/2023SE |
| K213883 | NanoZoomer S360MD Slide scanner systemPSY · Traditional | 09/27/2022SE |
| K162117 | NIRO-200NX DPMUD · Traditional | 10/25/2016SE |
| K133719 | Pde-NeoIZI · Traditional | 03/27/2014SE |
| K110480 | Pde Photodynamic EyeOWN · Traditional | 01/13/2012SE |
| K982171 | Hamamatsu PET Scanner, Model SHR-22000KPS · Traditional | 09/17/1998SE |
| K896331 | V2465P X-Ray Image IntensifierJAA · Traditional | 12/22/1989SE |
Questions and answers
When was NIRO-200NX cleared by the FDA?
NIRO-200NX (K143219) received a 510(k) decision of Substantially Equivalent on July 31, 2015, 263 days after the submission was received.
What is the product code of K143219?
The FDA product code is MUD – Oximeter, Tissue Saturation, a Class II (moderate risk) device regulated under 21 CFR 870.2700.