510(k) K102862
K102862 is an FDA 510(k) premarket notification submitted by Neurovision Medical Products, Inc. for the device "NEUROVISION SE (NERVEANA)". The FDA issued a decision of Substantially Equivalent on December 21, 2010. The device falls under product code ETN (Stimulator, Nerve), a Class II device regulated under 21 CFR 874.1820. Neurovision Medical Products, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 21, 2010
- Date Received
- September 30, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Nerve
- Device Class
- Class II
- Regulation Number
- 874.1820
- Review Panel
- EN
- Submission Type