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510(k) K052067

DOPPLER GUIDED PROCTOSCOPE, MODEL 500H by Multigon Industries, Inc. — Product Code JAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2005
Date Received
August 1, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Ultrasonic, Nonfetal
Device Class
Class II
Regulation Number
892.1540
Review Panel
RA
Submission Type

Other clearances by Multigon Industries, Inc.

  • K051739 — POCKET TRANSCRANIAL AND VASCULAR DOPPLER SPECTRUM ANALYZER, MODEL 500P; PW DOPPL (July 28, 2005)
  • K912044 — MODEL 700 LAPAROSCOPIC ELECTRONIC INSUFFLATOR (June 24, 1991)
  • K881263 — MODEL 500A VASCULAR SPECTRUM ANALYZER W/DOPPLER (January 5, 1990)
  • K882755 — MODEL 500V VASCULAR SPECTRUM ANALYZER (November 29, 1988)
  • K863589 — MODEL 600 VASCULAR DUPLEX IMAGER (June 24, 1987)
  • K860435 — MODEL 500A VASCULAR SPECTRUM ANALYZER W/CW DOPPLER (May 5, 1986)
  • K852680 — TRITON LAPAROSCOPIC COAGULATOR INSUFFLATOR & LAVAG (December 23, 1985)

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