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510(k) K030829

VPT METER by Xilas Medical, Inc. — Product Code LLN

K030829 is an FDA 510(k) premarket notification submitted by Xilas Medical, Inc. for the device "VPT METER". The FDA issued a decision of Substantially Equivalent on December 5, 2003. The device falls under product code LLN (Device, Vibration Threshold Measurement), a Class I device regulated under 21 CFR 882.1200. Xilas Medical, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2003
Date Received
March 14, 2003
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 Xilas Medical, Inc.

  • K050137 — TEMPTOUCH DERMAL THERMOMETER (March 18, 2005)

Other clearances for product code LLN

  • K072882 — PAIN VISION, MODEL PS-2100 (January 8, 2009)
  • 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)
  • K863607 — VIBRATRON II, VIBRATION SENSITIVITY TESTER (December 3, 1986)

FDA data resources