510(k) K874639
K874639 is an FDA 510(k) premarket notification submitted by Shimadzu Precision Instruments, Inc. for the device "REMOTE-CONTROLLED UNIVERSAL DIAG. TABLE RS-100". The FDA issued a decision of Substantially Equivalent on December 4, 1987. The device falls under product code KXJ (Table, Radiologic), a Class II device regulated under 21 CFR 892.1980. Shimadzu Precision Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 4, 1987
- Date Received
- November 12, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Table, Radiologic
- Device Class
- Class II
- Regulation Number
- 892.1980
- Review Panel
- RA
- Submission Type