510(k) K201800
K201800 is an FDA 510(k) premarket notification submitted by Nanoray Co., Ltd. for the device "Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X)". The FDA issued a decision of Substantially Equivalent on Dec 28, 2020. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 28, 2020
- Date Received
- Jun 30, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, X-Ray, Extraoral With Timer
- Device Class
- Class II
- Regulation Number
- 872.1800
- Review Panel
- RA
- Submission Type
- 510(k)