510(k) K861994
K861994 is an FDA 510(k) premarket notification submitted by Medicor USA , Ltd. for the device "MODEL RS-3I RADIOGRAPHIC/FLUROSCOPIC X-RAY SYSTEM". The FDA issued a decision of Substantially Equivalent on July 18, 1986. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Medicor USA , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 18, 1986
- Date Received
- May 23, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Stationary
- Device Class
- Class II
- Regulation Number
- 892.1680
- Review Panel
- RA
- Submission Type