510(k) K770333
K770333 is an FDA 510(k) premarket notification submitted by Litton Medical Systems for the device "FLUOROSCOPE, C-ARM". The FDA issued a decision of Substantially Equivalent on Mar 1, 1977. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Litton Medical Systems has 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 1, 1977
- Date Received
- Feb 18, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Fluoroscopic, Image-Intensified
- Device Class
- Class II
- Regulation Number
- 892.1650
- Review Panel
- RA
- Submission Type
- 510(k)