510(k) K961826
K961826 is an FDA 510(k) premarket notification submitted by Trophy Radiologie for the device "DIGIPAN". The FDA issued a decision of Substantially Equivalent on September 23, 1996. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. Trophy Radiologie has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 23, 1996
- Date Received
- May 13, 1996
- 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