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510(k) K052067

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

K052067 is an FDA 510(k) premarket notification submitted by Multigon Industries, Inc. for the device "DOPPLER GUIDED PROCTOSCOPE, MODEL 500H". The FDA issued a decision of Substantially Equivalent on August 29, 2005. The device falls under product code JAF (Monitor, Ultrasonic, Nonfetal), a Class II device regulated under 21 CFR 892.1540. Multigon Industries, Inc. has at least 7 other 510(k) clearances on record.

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)

Other clearances for product code JAF

  • K242487 — Laminar P1 (LDH-HW-001) (December 13, 2024)
  • K141657 — THD REVOLUTION (February 24, 2015)
  • K110628 — SIMPLEABI (May 12, 2011)
  • K093393 — LIFEDOP MODEL 300ABI (December 24, 2009)
  • K090009 — THD SLIDE ONE (January 28, 2009)
  • K081429 — THD SLIDE (July 30, 2008)
  • K070815 — THD (June 20, 2007)
  • K063600 — VISTA AVS (December 19, 2006)
  • K060064 — STETHOFLUX (April 10, 2006)
  • K010521 — NICOLET VERSALAB (March 9, 2001)

FDA data resources