510(k) K152767
K152767 is an FDA 510(k) premarket notification submitted by Del Medical, Inc. for the device "OTC12D AUTO RADIOGRAPHIC SYSTEM". The FDA issued a decision of Substantially Equivalent on December 14, 2015. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Del Medical, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 14, 2015
- Date Received
- September 24, 2015
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Stationary
- Device Class
- Class II
- Regulation Number
- 892.1680
- Review Panel
- RA
- Submission Type