510(k) K200284
K200284 is an FDA 510(k) premarket notification submitted by Remedi Co., Ltd. for the device "R-Sensor, R-Sensor". The FDA issued a decision of Substantially Equivalent on Feb 28, 2020. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Remedi Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 28, 2020
- Date Received
- Feb 5, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Extraoral Source, Digital
- Device Class
- Class II
- Regulation Number
- 872.1800
- Review Panel
- RA
- Submission Type