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510(k) K853608

NEUROMETER by Neurotron, Inc. — Product Code LLN

K853608 is an FDA 510(k) premarket notification submitted by Neurotron, Inc. for the device "NEUROMETER". The FDA issued a decision of Substantially Equivalent on June 12, 1986. The device falls under product code LLN (Device, Vibration Threshold Measurement), a Class I device regulated under 21 CFR 882.1200. Neurotron, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 1986
Date Received
August 28, 1985
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 Neurotron, Inc.

  • K843924 — DIGITAL ELECTRONEUROMETER S-100 (March 12, 1985)

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