510(k) K200141
K200141 is an FDA 510(k) premarket notification submitted by Ld Technology, LLC for the device "Oxi-W System". The FDA issued a decision of Substantially Equivalent on April 27, 2020. The device falls under product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.2300. Ld Technology, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 27, 2020
- Date Received
- January 21, 2020
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- Device Class
- Class II
- Regulation Number
- 870.2300
- Review Panel
- CV
- Submission Type