510(k) K992194
K992194 is an FDA 510(k) premarket notification submitted by Ad-Tech Medical Instrument Corp for the device "CORTICAL MAPPING UNIT, MODEL CMU". The FDA issued a decision of Substantially Equivalent on September 13, 1999. The device falls under product code GYC (Electrode, Cortical), a Class II device regulated under 21 CFR 882.1310. Ad-Tech Medical Instrument Corp has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 13, 1999
- Date Received
- June 29, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Cortical
- Device Class
- Class II
- Regulation Number
- 882.1310
- Review Panel
- NE
- Submission Type