510(k) K940085
K940085 is an FDA 510(k) premarket notification submitted by Sense Technology, Inc. for the device "FORCE RECORDING AND ANALYSIS SYSTEM, MODEL 01". The FDA issued a decision of Substantially Equivalent on December 7, 1994. The device falls under product code LXM (Manipulator, Plunger-Like Joint), a Class U device. Sense Technology, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 7, 1994
- Date Received
- January 7, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Manipulator, Plunger-Like Joint
- Device Class
- Class U
- Regulation Number
- Review Panel
- PM
- Submission Type