510(k) K951176
K951176 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. for the device "KOORDINAT M". The FDA issued a decision of Substantially Equivalent on April 20, 1995. The device falls under product code IXR (Table, Radiographic, Tilting), a Class II device regulated under 21 CFR 892.1980. Siemens Medical Solutions USA, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 20, 1995
- Date Received
- March 15, 1995
- 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