510(k) K153426
K153426 is an FDA 510(k) premarket notification submitted by Modulated Imaging, Inc. for the device "Ox-Imager CS". The FDA issued a decision of Substantially Equivalent on Dec 21, 2016. The device falls under product code MUD (Oximeter, Tissue Saturation), a Class II device regulated under 21 CFR 870.2700. Modulated Imaging, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 21, 2016
- Date Received
- Nov 25, 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
- 510(k)