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510(k) K934368

NK PRESSURE-SPECIFIED SENSORY DEVICE, MODEL PSSD-001 by Nk Biotechnical Engineering Co. — Product Code LLN

K934368 is an FDA 510(k) premarket notification submitted by Nk Biotechnical Engineering Co. for the device "NK PRESSURE-SPECIFIED SENSORY DEVICE, MODEL PSSD-001". The FDA issued a decision of Substantially Equivalent on August 11, 1994. The device falls under product code LLN (Device, Vibration Threshold Measurement), a Class I device regulated under 21 CFR 882.1200. Nk Biotechnical Engineering Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1994
Date Received
September 7, 1993
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 Nk Biotechnical Engineering Co.

  • K923964 — NK GRASP SENSOR, MODEL GA001 (May 12, 1993)
  • K923965 — NK GRASP SENSOR, MODEL GA002 (May 12, 1993)
  • K923963 — NK DIGI-GRIP SENSOR, MODEL DGR001 (March 31, 1993)
  • K921266 — NK MEDICAL MICROMETER, MODEL MC001 (July 14, 1992)
  • K921268 — NK DYNA-GRIP SENSOR, MODEL DG001 (July 14, 1992)
  • K914059 — NK DEVIATION SENSOR, MODEL DV001 (December 9, 1991)
  • K914062 — NK DEXTERITLY BOARD, MODEL BX001 (December 9, 1991)
  • K914055 — PINCH SENSOR, MODEL PF001 (December 9, 1991)
  • K914054 — NK GRASP SENSOR, MODEL GR001 (December 9, 1991)
  • K914060 — RANGE OF MOTION SENSOR, MODEL RM001 (December 9, 1991)

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)
  • 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