510(k) K800839
K800839 is an FDA 510(k) premarket notification submitted by Medefield Pty. , Ltd. for the device "MEDESCAN". The FDA issued a decision of Substantially Equivalent on May 30, 1980. The device falls under product code KTA (Medium, Contrast, Radiologic), a Class U device. Medefield Pty. , Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 30, 1980
- Date Received
- April 15, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Medium, Contrast, Radiologic
- Device Class
- Class U
- Regulation Number
- Review Panel
- RA
- Submission Type