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510(k) K964815

AP-4000, AIR PULSE SENSORY STIMULATOR by Pentax Precision Instrument Corp. — Product Code LLN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 1997
Date Received
November 29, 1996
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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  • K023376 — EB-1830T3, VIDEO BRONCHOSCOPE (October 16, 2002)
  • K021276 — FG-36UX FIBER ULTRASOUND GASTROSCOPE (September 12, 2002)
  • K021278 — EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE (September 6, 2002)
  • K013640 — EG-3630UR, ULTRASUND VIDEO GASTROSCOPE (February 4, 2002)
  • K010740 — FG-36UX, FIBER ULTRASOUND GASTROSCOPE (April 17, 2001)

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  • K863607 — VIBRATRON II, VIBRATION SENSITIVITY TESTER (December 3, 1986)