510(k) K242726
K242726 is an FDA 510(k) premarket notification submitted by Inventis S.R.L. for the device "Synapsys VHIT". The FDA issued a decision of Substantially Equivalent on January 3, 2025. The device falls under product code GWN (Nystagmograph), a Class II device regulated under 21 CFR 882.1460. Inventis S.R.L. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 3, 2025
- Date Received
- September 10, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nystagmograph
- Device Class
- Class II
- Regulation Number
- 882.1460
- Review Panel
- NE
- Submission Type