510(k) K973914
K973914 is an FDA 510(k) premarket notification submitted by Sense Technology, Inc. for the device "SENSE TECHNOLOGY INC. FRAS, SENSE TECHNOLOGY INC. PULSTAR". The FDA issued a decision of Substantially Equivalent on Jun 30, 1998. 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
- Jun 30, 1998
- Date Received
- Oct 14, 1997
- 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