510(k) K081540
K081540 is an FDA 510(k) premarket notification submitted by Peter Fischer for the device "ZEGRA POSTURE TRAINER". The FDA issued a decision of Substantially Equivalent on February 20, 2009. The device falls under product code LZW (Monitor, Spine Curvature), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 20, 2009
- Date Received
- June 2, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Spine Curvature
- Device Class
- Class U
- Regulation Number
- Review Panel
- PM
- Submission Type