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510(k) K864345

NTE-2 THERMAL SENSITIVITY TESTER by Sensortek, Inc. — Product Code LQW

K864345 is an FDA 510(k) premarket notification submitted by Sensortek, Inc. for the device "NTE-2 THERMAL SENSITIVITY TESTER". The FDA issued a decision of Substantially Equivalent on January 29, 1987. The device falls under product code LQW (Test, Temperature Discrimination), a Class I device regulated under 21 CFR 882.1200. Sensortek, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 1987
Date Received
November 4, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Temperature Discrimination
Device Class
Class I
Regulation Number
882.1200
Review Panel
NE
Submission Type

Other clearances by Sensortek, Inc.

  • K863607 — VIBRATRON II, VIBRATION SENSITIVITY TESTER (December 3, 1986)
  • K852228 — ESOPHAGEAL STETHOSCOPE WITH ELECTRICAL CONDUCTORS (September 3, 1985)
  • K844056 — THERMOCOUPLE SENSORS, ACCESS. FOR ELECTRONIC THERM (January 9, 1985)
  • K844055 — ESOPHAGEAL STETHO SCOPE (October 25, 1984)

Other clearances for product code LQW

  • K141208 — DYNAMIC NEUROSCREENING DEVICE (July 23, 2014)
  • K922052 — TSA 2001 THERMAL SENSORY ANALYZER (October 21, 1993)

FDA data resources