510(k) K980866
K980866 is an FDA 510(k) premarket notification submitted by Neuro-Diagnostic Assoc. for the device "MEDI-DX 7000 CPT WITH AMREX ELECTRODES". The FDA issued a decision of Substantially Equivalent on May 20, 1998. The device falls under product code GWF (Stimulator, Electrical, Evoked Response), a Class II device regulated under 21 CFR 882.1870. Neuro-Diagnostic Assoc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 20, 1998
- Date Received
- February 19, 1998
- 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