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510(k) K863607

VIBRATRON II, VIBRATION SENSITIVITY TESTER by Sensortek, Inc. — Product Code LLN

K863607 is an FDA 510(k) premarket notification submitted by Sensortek, Inc. for the device "VIBRATRON II, VIBRATION SENSITIVITY TESTER". The FDA issued a decision of Substantially Equivalent on December 3, 1986. The device falls under product code LLN (Device, Vibration Threshold Measurement), 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
December 3, 1986
Date Received
September 16, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Vibration Threshold Measurement
Device Class
Class I
Regulation Number
882.1200
Review Panel
NE
Submission Type

Other clearances by Sensortek, Inc.

  • K864345 — NTE-2 THERMAL SENSITIVITY TESTER (January 29, 1987)
  • 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 LLN

  • K072882 — PAIN VISION, MODEL PS-2100 (January 8, 2009)
  • K030829 — VPT METER (December 5, 2003)
  • K010981 — GSA GENITO SENSORY ANALYZER (September 20, 2001)
  • K964622 — MEDI-DX 7000 (December 1, 1997)
  • K964815 — AP-4000, AIR PULSE SENSORY STIMULATOR (September 4, 1997)
  • K970180 — VSA 3000 VIBRATORYN SENSORY ANALYZER (April 25, 1997)
  • K934368 — NK PRESSURE-SPECIFIED SENSORY DEVICE, MODEL PSSD-001 (August 11, 1994)
  • K921560 — VIBROTACTILE TESTER, MODEL NO. VTT-100 (October 30, 1992)
  • K910624 — CASE IV COMPUTER AIDED SENSORY EVALUATOR VERSION 4 (January 17, 1992)
  • K872931 — TECA/MEDELEC TTT THERMAL THRESHOLD TESTER (November 16, 1987)

FDA data resources