510(k) K952294
K952294 is an FDA 510(k) premarket notification submitted by Computational Diagnostics, Inc. for the device "NEURONET". The FDA issued a decision of Substantially Equivalent on Jan 26, 1996. The device falls under product code GWF (Stimulator, Electrical, Evoked Response), a Class II device regulated under 21 CFR 882.1870.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 26, 1996
- Date Received
- May 16, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Electrical, Evoked Response
- Device Class
- Class II
- Regulation Number
- 882.1870
- Review Panel
- NE
- Submission Type
- 510(k)