510(k) K770220
K770220 is an FDA 510(k) premarket notification submitted by G.D. Searle And Co. for the device "RADIONUCLIDE COMPUTED TOMOGRAPHY SYS.". The FDA issued a decision of Substantially Equivalent on Feb 28, 1977. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200. G.D. Searle And Co. has 55 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 28, 1977
- Date Received
- Feb 3, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- System, Tomography, Computed, Emission
- Device Class
- Class II
- Regulation Number
- 892.1200
- Review Panel
- RA
- Submission Type
- 510(k)