510(k) K781287
K781287 is an FDA 510(k) premarket notification submitted by Siemens Corp. for the device "DENTAL X-RAY UNIT W/CEPHALOMETRIC ATTACH". The FDA issued a decision of Substantially Equivalent on September 11, 1978. The device falls under product code EAG (Cephalometer), a Class II device regulated under 21 CFR 872.1830. Siemens Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 11, 1978
- Date Received
- July 26, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cephalometer
- Device Class
- Class II
- Regulation Number
- 872.1830
- Review Panel
- RA
- Submission Type