510(k) K760808
K760808 is an FDA 510(k) premarket notification submitted by G.D. Searle And Co. for the device "PHO. TRAX MODEL 4000 WHOLE BODY SCAN.". The FDA issued a decision of Substantially Equivalent on Nov 5, 1976. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. G.D. Searle And Co. has 55 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 5, 1976
- Date Received
- Oct 12, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- System, X-Ray, Tomography, Computed
- Device Class
- Class II
- Regulation Number
- 892.1750
- Review Panel
- RA
- Submission Type
- 510(k)