510(k) K162117
K162117 is an FDA 510(k) premarket notification submitted by Hamamatsu Photonics K.K. for the device "NIRO-200NX DP". The FDA issued a decision of Substantially Equivalent on October 25, 2016. The device falls under product code MUD (Oximeter, Tissue Saturation), a Class II device regulated under 21 CFR 870.2700. Hamamatsu Photonics K.K. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 25, 2016
- Date Received
- July 29, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Oximeter, Tissue Saturation
- Device Class
- Class II
- Regulation Number
- 870.2700
- Review Panel
- SU
- Submission Type