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510(k) K904832

MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST by Hewlett-Packard Co. — Product Code DXK

K904832 is an FDA 510(k) premarket notification submitted by Hewlett-Packard Co. for the device "MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST". The FDA issued a decision of Substantially Equivalent on April 22, 1991. The device falls under product code DXK (Echocardiograph), a Class II device regulated under 21 CFR 870.2330. Hewlett-Packard Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 1991
Date Received
October 23, 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 Hewlett-Packard Co.

  • K992543 — HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGER, DATA CARD, SINGLE (May 18, 2000)
  • K993383 — HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS M300 (February 3, 2000)
  • K992273 — HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR M3000A/M304 (January 28, 2000)
  • K993587 — HP M2376A DEVICE LINK SYSTEM (January 20, 2000)
  • K993169 — MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A (December 20, 1999)
  • K992595 — HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K WITH EASI-ST SEGMENT MEASUR (December 8, 1999)
  • K992977 — HEWLETT PACKARD MULTIFUNCTION PEDIATRIC DEFIB FUNCTION, MODEL M3503A & M3504A (December 1, 1999)
  • K992674 — HP VIRIDIA CMS PATIENT MONITOR WITH EEG PARAMETER, MODEL M1027A (November 8, 1999)
  • K993516 — HP M2600A VIRIDIA TELEMETRY SYSTEM (November 8, 1999)
  • K993171 — HP VIRIDIA INFORMATION SYSTEM, MODELS M3150A/ M3151A/ M3153A/ M3154A (October 21, 1999)

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)
  • 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)
  • K904978 — SOFTWARE PROGRAM USED W/PRISM PRODUCTS (February 25, 1991)

FDA data resources