510(k) K890495
K890495 is an FDA 510(k) premarket notification submitted by Nicolet Instrument Corp. for the device "NICOLET VIKING II SYSTEM". The FDA issued a decision of Substantially Equivalent on March 16, 1989. The device falls under product code IKN (Electromyograph, Diagnostic), a Class II device regulated under 21 CFR 890.1375. Nicolet Instrument Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 16, 1989
- Date Received
- February 1, 1989
- 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