510(k) K151305
K151305 is an FDA 510(k) premarket notification submitted by Nonin Medical, Inc. for the device "SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg)". The FDA issued a decision of Substantially Equivalent on August 27, 2015. The device falls under product code MUD (Oximeter, Tissue Saturation), a Class II device regulated under 21 CFR 870.2700. Nonin Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 27, 2015
- Date Received
- May 18, 2015
- 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