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510(k) K901592

MODEL MD-5 DOPPLER by D. E. Hokanson, Inc. — Product Code DXK

K901592 is an FDA 510(k) premarket notification submitted by D. E. Hokanson, Inc. for the device "MODEL MD-5 DOPPLER". The FDA issued a decision of Substantially Equivalent on October 22, 1990. The device falls under product code DXK (Echocardiograph), a Class II device regulated under 21 CFR 870.2330. D. E. Hokanson, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 1990
Date Received
April 5, 1990
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 D. E. Hokanson, Inc.

  • K041689 — POLYURETHANE BLOOD PRESSURE CUFFS (August 6, 2004)
  • K033156 — OB1 OBSTETRICAL DOPPLER (December 9, 2003)
  • K023707 — A16 BLOOD FLOW MEASUREMENT SYSTEM (February 12, 2003)
  • K982707 — EC6 PLETHYSMOGRAPH (August 26, 1998)
  • K973426 — ANS 2000 ECG MONITOR AND RESPIRATION PACER (August 12, 1998)
  • K970570 — NIVP3 (WINDOWS VERSION OF NIVP (October 3, 1997)
  • K932852 — NON INVASIVE VASCULAR PROGRAM (February 4, 1994)
  • K932812 — EC 5R PLETHYSMOGRAPH (January 13, 1994)
  • K932851 — DISPOSABLE PENILE BLOOD PRESSURE CUFFS (November 15, 1993)
  • K905367 — E-20 RAPID CUFF INFLATOR (March 6, 1991)

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