510(k) K021372
K021372 is an FDA 510(k) premarket notification submitted by J. Morita USA, Inc. for the device "VERAVIEWEPOCS PANORAMIC X-RAY UNIT WITH CEPHALOMETRIC CAPABILITY". The FDA issued a decision of Substantially Equivalent on June 7, 2002. The device falls under product code EAG (Cephalometer), a Class II device regulated under 21 CFR 872.1830. J. Morita USA, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 7, 2002
- Date Received
- April 30, 2002
- 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