510(k) K051448

Device: MODIFIED CONTACT-HEAT EVOKED POTENTIAL STIMULATOR (CHEPS)
Applicant: MEDOC LTD. ADVANCED MEDICAL SYSTEMS
510(k) number: K051448
Product code: NTU
Decision: Substantially Equivalent (SESE)
Decision date: 2005-06-29
Date received: 2005-06-02
Regulation: 882.1870
Classification name: Evoked Potential Stimulator, Thermal
Medical specialty: Neurology
Review panel: Neurology
Device class: 2
Clearance type: Special
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: GEORGE J HATTUB
Address: 291 Hillside Ave. Somerset MA US 02726 02726

FDA Registration Numbers#

8044062

Source Documents#

Other 510(k) Records For Product Code NTU #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K052357	PATHWAY - ATS/CHEPS	Medoc Ltd. Advanced Medical Systems	2006-01-19
K041908	CONTACT HEAT-EVOKED POTENTIAL STIMULATOR (CHEPS)	Medoc Ltd. Advanced Medical Systems	2005-02-25

Legacy Summary#

summary

FDA Review#

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