510(k) K171245
K171245 is an FDA 510(k) premarket notification submitted by Christie Medical Holdings, Inc. for the device "Presygen/si-1". The FDA issued a decision of Substantially Equivalent on Aug 9, 2018. The device falls under product code MUD (Oximeter, Tissue Saturation), a Class II device regulated under 21 CFR 870.2700.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 9, 2018
- Date Received
- Apr 28, 2017
- 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)