The following data is part of a premarket notification filed by Hamamatsu Photonics K.k. with the FDA for Niro-200nx.
| Device ID | K143219 |
| 510k Number | K143219 |
| Device Name: | NIRO-200NX |
| Classification | Oximeter, Tissue Saturation |
| Applicant | Hamamatsu Photonics K.K. 812 Joko-cho Highashi-ku Hamamatsu City, JP 431-3196 |
| Contact | Susumu Suzuki |
| Correspondent | Jeffrey K. Shapiro HYMAN, PHELPS & MCNAMARA. P.C. 700 THIRTEENTH STREET N.W. SUITE 1200 Washington, DC 20005 |
| Product Code | MUD |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-10 |
| Decision Date | 2015-07-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04582389010062 | K143219 | 000 |