510(k) K982103
K982103 is an FDA 510(k) premarket notification submitted by Synapsys, Inc. for the device "ULMER (VNG) VIDEO NYSTAGMOGRAPH". The FDA issued a decision of Substantially Equivalent on September 11, 1998. The device falls under product code GWN (Nystagmograph), a Class II device regulated under 21 CFR 882.1460. Synapsys, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 11, 1998
- Date Received
- June 15, 1998
- 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