510(k) K051448
K051448 is an FDA 510(k) premarket notification submitted by Medoc Ltd. Advanced Medical Systems for the device "MODIFIED CONTACT-HEAT EVOKED POTENTIAL STIMULATOR (CHEPS)". The FDA issued a decision of Substantially Equivalent on June 29, 2005. The device falls under product code NTU (Evoked Potential Stimulator, Thermal), a Class II device regulated under 21 CFR 882.1870. Medoc Ltd. Advanced Medical Systems has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 29, 2005
- Date Received
- June 2, 2005
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Evoked Potential Stimulator, Thermal
- Device Class
- Class II
- Regulation Number
- 882.1870
- Review Panel
- NE
- Submission Type
Intended to evaluate the functionality of human pain reception and transmission of sensory pathways