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510(k) K041396

FG-36UX FIBER ULTRASOUND GASTROSCOPE by Pentax Precision Instrument Corp. — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2004
Date Received
May 26, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Transducer, Ultrasonic, Diagnostic
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
Submission Type

Other clearances by Pentax Precision Instrument Corp.

  • K041397 — EG-3830UT (June 9, 2004)
  • K041395 — EG-3630UR (June 9, 2004)
  • K031789 — EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE (August 8, 2003)
  • K023401 — EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE (February 11, 2003)
  • 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)
  • K964815 — AP-4000, AIR PULSE SENSORY STIMULATOR (September 4, 1997)

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