The following data is part of a premarket notification filed by Hamamatsu Photonics K.k. with the FDA for Niro-200nx Dp.
| Device ID | K162117 |
| 510k Number | K162117 |
| Device Name: | NIRO-200NX DP |
| Classification | Oximeter, Tissue Saturation |
| Applicant | Hamamatsu Photonics K.K. 812 Joko-cho, Higashi-ku Hamamatsu City, JP 431-3196 |
| Contact | Susumu Suzuki |
| Correspondent | Allyson B. Mullen Hyman, Phelps & McNamara 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 | 2016-07-29 |
| Decision Date | 2016-10-25 |
| Summary: | summary |