510(k) K102610
K102610 is an FDA 510(k) premarket notification submitted by Teleemg, LLC USA for the device "FOCUS EMG DEVICE". The FDA issued a decision of Substantially Equivalent on March 4, 2011. The device falls under product code IKN (Electromyograph, Diagnostic), a Class II device regulated under 21 CFR 890.1375. Teleemg, LLC USA has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 4, 2011
- Date Received
- September 10, 2010
- 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