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510(k) K041908

Device
CONTACT HEAT-EVOKED POTENTIAL STIMULATOR (CHEPS)
Applicant
MEDOC LTD. ADVANCED MEDICAL SYSTEMS
510(k) number
K041908
Product code
NTU  
Decision
Substantially Equivalent (SESE)
Decision date
2005-02-25
Date received
2004-07-15
Regulation
882.1870
Classification name
Evoked Potential Stimulator, Thermal
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
TRACY GRAY
Address
4050 Olson Memorial Hwy. Suite 350 Minneapolis MN US 55422 55422

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NTU  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K052357PATHWAY - ATS/CHEPSMedoc Ltd. Advanced Medical Systems2006-01-19
K051448MODIFIED CONTACT-HEAT EVOKED POTENTIAL STIMULATOR (CHEPS)Medoc Ltd. Advanced Medical Systems2005-06-29

Legacy Summary#

summary

FDA Review#

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