Modified Syst: Sonos 500/1000 Ultrsound Imag Syst

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K904832 ↗

FDA Product Code

DXK

Device Class

Class II

Regulation

21 CFR Part 870.2330

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Luer Lock Skirt

  Class II

  FDA 510(k) K862451 Active Cleared 31 Oct 1986

• Hp Sonos 100 Cf Ultrasound Imaging System

  Class II

  FDA 510(k) K922184 Active Cleared 30 Jul 1992

• Medical Diag. Ultrasound Instr. 77065

  Class II

  FDA 510(k) K842897 Active Cleared 25 Sep 1984

• Model M1403A Telemetry Monitoring Systems (TMS)

  Class II

  FDA 510(k) K913533 Active Cleared 7 Nov 1991

• Differential Refractive Index Detector

  Class I

  FDA 510(k) K800556 Active Cleared 25 Mar 1980

• Model 80100A, Patient Data Memory

  Class II

  FDA 510(k) K781360 Active Cleared 7 Sep 1978

See all devices from Hewlett-Packard Co. →

• What is the primary clinical application for the Sonos 500/1000?

  The Sonos 500/1000 is an echocardiograph device specifically designed to perform ultrasound imaging for cardiovascular applications.

• What is the regulatory classification of this imaging system?

  This device is classified as a Class II medical device under regulation number 870.2330. It received FDA 510(k) clearance on April 22, 1991, under submission number K904832, confirming it was found to be substantially equivalent to existing predicate devices.

• Who is the manufacturer of the Sonos 500/1000?

  The device is manufactured by Hewlett-Packard Co., located in Andover, Massachusetts.