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510(k) K052357

PATHWAY - ATS/CHEPS by Medoc Ltd. Advanced Medical Systems — Product Code NTU

K052357 is an FDA 510(k) premarket notification submitted by Medoc Ltd. Advanced Medical Systems for the device "PATHWAY - ATS/CHEPS". The FDA issued a decision of Substantially Equivalent on January 19, 2006. 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
January 19, 2006
Date Received
August 29, 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

Other clearances by Medoc Ltd. Advanced Medical Systems

  • K051448 — MODIFIED CONTACT-HEAT EVOKED POTENTIAL STIMULATOR (CHEPS) (June 29, 2005)
  • K041908 — CONTACT HEAT-EVOKED POTENTIAL STIMULATOR (CHEPS) (February 25, 2005)
  • K010981 — GSA GENITO SENSORY ANALYZER (September 20, 2001)

Other clearances for product code NTU

  • K051448 — MODIFIED CONTACT-HEAT EVOKED POTENTIAL STIMULATOR (CHEPS) (June 29, 2005)
  • K041908 — CONTACT HEAT-EVOKED POTENTIAL STIMULATOR (CHEPS) (February 25, 2005)

FDA data resources