510(k) K031930
K031930 is an FDA 510(k) premarket notification submitted by Medical Measurement Systems B.V. for the device "HIGH SPEED EMG MODULE". The FDA issued a decision of Substantially Equivalent on Mar 3, 2004. The device falls under product code GWF (Stimulator, Electrical, Evoked Response), a Class II device regulated under 21 CFR 882.1870. Medical Measurement Systems B.V. has 6 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 3, 2004
- Date Received
- Jun 23, 2003
- 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)