510(k) K964325
K964325 is an FDA 510(k) premarket notification submitted by Micromedical Technologies, Inc. for the device "VISUALEYES: VIDEO EYE MONITOR". The FDA issued a decision of Substantially Equivalent on July 15, 1997. The device falls under product code GWN (Nystagmograph), a Class II device regulated under 21 CFR 882.1460. Micromedical Technologies, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 15, 1997
- Date Received
- October 30, 1996
- 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