510(k) K191676
K191676 is an FDA 510(k) premarket notification submitted by Vioptix, Inc. for the device "Intra.Ox 2.0 Handheld Tissue Oximeter". The FDA issued a decision of Substantially Equivalent on September 16, 2019. The device falls under product code MUD (Oximeter, Tissue Saturation), a Class II device regulated under 21 CFR 870.2700. Vioptix, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 16, 2019
- Date Received
- June 24, 2019
- 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