510(k) K964460
K964460 is an FDA 510(k) premarket notification submitted by Shai Syg Motion and Innovations, Ltd. for the device "THE ROBOLITE". The FDA issued a decision of Substantially Equivalent on January 24, 1997. The device falls under product code JQP (Calculator/Data Processing Module, For Clinical Use), a Class I device regulated under 21 CFR 862.2100. Shai Syg Motion and Innovations, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 24, 1997
- Date Received
- November 7, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calculator/Data Processing Module, For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2100
- Review Panel
- CH
- Submission Type