510(k) K142494
K142494 is an FDA 510(k) premarket notification submitted by Dorsavi, Ltd. for the device "ViMove". The FDA issued a decision of Substantially Equivalent on May 28, 2015. The device falls under product code IKN (Electromyograph, Diagnostic), a Class II device regulated under 21 CFR 890.1375. Dorsavi, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 28, 2015
- Date Received
- September 5, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electromyograph, Diagnostic
- Device Class
- Class II
- Regulation Number
- 890.1375
- Review Panel
- NE
- Submission Type