510(k) K973039
K973039 is an FDA 510(k) premarket notification submitted by GE Medical Systems for the device "LEGACY/LEGACY-D TABLE". The FDA issued a decision of Substantially Equivalent on October 16, 1997. The device falls under product code IXR (Table, Radiographic, Tilting), a Class II device regulated under 21 CFR 892.1980. GE Medical Systems has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 16, 1997
- Date Received
- August 14, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Table, Radiographic, Tilting
- Device Class
- Class II
- Regulation Number
- 892.1980
- Review Panel
- RA
- Submission Type