510(k) K162603
K162603 is an FDA 510(k) premarket notification submitted by Masimo Corporation for the device "Masimo O3 Regional Oximeter System". The FDA issued a decision of Substantially Equivalent on May 26, 2017. The device falls under product code MUD (Oximeter, Tissue Saturation), a Class II device regulated under 21 CFR 870.2700. Masimo Corporation has 86 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 26, 2017
- Date Received
- Sep 19, 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
- 510(k)