510(k) K170967
K170967 is an FDA 510(k) premarket notification submitted by Skanray Technologies Private Limited for the device "Intraskan DC Plus". The FDA issued a decision of Substantially Equivalent on June 8, 2017. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. Skanray Technologies Private Limited has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 8, 2017
- Date Received
- March 31, 2017
- Clearance Type
- Special
- 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