510(k) K792326
K792326 is an FDA 510(k) premarket notification submitted by Tecnomed, Inc. for the device "HILO TRANS-X TRAUMA TRANSPORT". The FDA issued a decision of Substantially Equivalent on Jan 28, 1980. The device falls under product code IXR (Table, Radiographic, Tilting), a Class II device regulated under 21 CFR 892.1980. Tecnomed, Inc. has 17 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 28, 1980
- Date Received
- Nov 19, 1979
- 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
- 510(k) Exempt