510(k) K781936
K781936 is an FDA 510(k) premarket notification submitted by Emi Medical, Inc. for the device "SCANNER-EMI 7020 AND 7020R". The FDA issued a decision of Substantially Equivalent on December 4, 1978. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Emi Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 4, 1978
- Date Received
- November 20, 1978
- 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