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510(k) K864345

Device
NTE-2 THERMAL SENSITIVITY TESTER
Applicant
SENSORTEK, INC.
510(k) number
K864345
Product code
LQW  
Decision
Substantially Equivalent (SESE)
Decision date
1987-01-29
Date received
1986-11-04
Regulation
882.1200
Classification name
Test, Temperature Discrimination
Medical specialty
Neurology
Review panel
Neurology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
RONALD FELLER
Address
154 Huron Ave. Clifton NJ US 07013 07013

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LQW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K141208DYNAMIC NEUROSCREENING DEVICEProsenex2014-07-23
K922052TSA 2001 THERMAL SENSORY ANALYZERMedoc Corp.1993-10-21

Legacy Summary#

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FDA Review#

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