510(k) K192629
K192629 is an FDA 510(k) premarket notification submitted by Optima Health Solutions International Corp. for the device "Spinalytics". The FDA issued a decision of Substantially Equivalent on December 21, 2019. The device falls under product code LXM (Manipulator, Plunger-Like Joint), a Class U device. Optima Health Solutions International Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 21, 2019
- Date Received
- September 23, 2019
- 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