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510(k) K921560

VIBROTACTILE TESTER, MODEL NO. VTT-100 by Topical Testing, Inc. — Product Code LLN

K921560 is an FDA 510(k) premarket notification submitted by Topical Testing, Inc. for the device "VIBROTACTILE TESTER, MODEL NO. VTT-100". The FDA issued a decision of Substantially Equivalent on October 30, 1992. The device falls under product code LLN (Device, Vibration Threshold Measurement), a Class I device regulated under 21 CFR 882.1200.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1992
Date Received
April 1, 1992
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

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  • K934368 — NK PRESSURE-SPECIFIED SENSORY DEVICE, MODEL PSSD-001 (August 11, 1994)
  • K910624 — CASE IV COMPUTER AIDED SENSORY EVALUATOR VERSION 4 (January 17, 1992)
  • K872931 — TECA/MEDELEC TTT THERMAL THRESHOLD TESTER (November 16, 1987)
  • K863607 — VIBRATRON II, VIBRATION SENSITIVITY TESTER (December 3, 1986)

FDA data resources