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510(k) K863589

MODEL 600 VASCULAR DUPLEX IMAGER by Multigon Industries, Inc. — Product Code DXK

K863589 is an FDA 510(k) premarket notification submitted by Multigon Industries, Inc. for the device "MODEL 600 VASCULAR DUPLEX IMAGER". The FDA issued a decision of Substantially Equivalent on June 24, 1987. The device falls under product code DXK (Echocardiograph), a Class II device regulated under 21 CFR 870.2330. Multigon Industries, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1987
Date Received
September 15, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Echocardiograph
Device Class
Class II
Regulation Number
870.2330
Review Panel
CV
Submission Type

Other clearances by Multigon Industries, Inc.

  • K052067 — DOPPLER GUIDED PROCTOSCOPE, MODEL 500H (August 29, 2005)
  • 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)
  • 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 DXK

  • K181042 — Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter (May 17, 2018)
  • K160173 — Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz Intr (February 26, 2016)
  • K031148 — IN-VISION IMAGING SYSTEM (May 28, 2003)
  • K934887 — 9750 ATHENA ETHERNET OPTION (January 14, 1994)
  • K913209 — ACCESSORY TO GENESIS III (GCFM) (May 15, 1992)
  • K911384 — CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600 (June 25, 1991)
  • K904832 — MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST (April 22, 1991)
  • K904977 — CINE/VIEW PLUS - CARDIOLOGY WORKSTATION (February 25, 1991)
  • K904976 — CINE'VIEW - STRESS ECHO & IMAGE REVIEW (February 25, 1991)
  • K904975 — VISTA VIEWING STATION (February 25, 1991)

FDA data resources