510(k) K232385
K232385 is an FDA 510(k) premarket notification submitted by Iss Medical, Inc. for the device "OxiplexTS200". The FDA issued a decision of Substantially Equivalent on March 1, 2024. 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
- March 1, 2024
- Date Received
- August 9, 2023
- 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