510(k) K811197
K811197 is an FDA 510(k) premarket notification submitted by Tecnomed, Inc. for the device "SUPERIX 120". The FDA issued a decision of Substantially Equivalent on Jun 9, 1981. The device falls under product code IZF (System, X-Ray, Tomographic), a Class II device regulated under 21 CFR 892.1740. Tecnomed, Inc. has 17 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 9, 1981
- Date Received
- Apr 30, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Tomographic
- Device Class
- Class II
- Regulation Number
- 892.1740
- Review Panel
- RA
- Submission Type
- 510(k)