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510(k) K903414

TRANSESOPHAGEAL PROBE HOLDER & DISINFECTING COLUMN by Echo Ultrasound — Product Code DXK

K903414 is an FDA 510(k) premarket notification submitted by Echo Ultrasound for the device "TRANSESOPHAGEAL PROBE HOLDER & DISINFECTING COLUMN". The FDA issued a decision of Substantially Equivalent on September 19, 1990. The device falls under product code DXK (Echocardiograph), a Class II device regulated under 21 CFR 870.2330. Echo Ultrasound has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 1990
Date Received
July 30, 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 Echo Ultrasound

  • K924054 — PHONOCARDIOGRAPH (January 22, 1993)
  • K893225 — COUPLANT WARMING DEVICE (October 12, 1989)
  • K872519 — STERILIZED OMNI GEL (August 3, 1987)
  • K844120 — ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS (January 23, 1985)
  • K844034 — SONOCARE (January 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