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510(k) K900560

ACUSON HEARTSOUND/PULSE/RESPIRATION MODULE by Acuson Corp. — Product Code DQC

K900560 is an FDA 510(k) premarket notification submitted by Acuson Corp. for the device "ACUSON HEARTSOUND/PULSE/RESPIRATION MODULE". The FDA issued a decision of Substantially Equivalent on December 3, 1990. The device falls under product code DQC (Phonocardiograph), a Class I device regulated under 21 CFR 870.2390. Acuson Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1990
Date Received
February 7, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Phonocardiograph
Device Class
Class I
Regulation Number
870.2390
Review Panel
CV
Submission Type

Other clearances by Acuson Corp.

  • K023772 — KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM (November 22, 2002)
  • K022896 — CSV12 SOFTWARE VIEWER (October 3, 2002)
  • K022567 — SEQUOIA SIGNATURE II DIAGNOSTIC ULTRASOUND SYSTEM (August 13, 2002)
  • K021497 — CYPRESS ULTRASOUND SYSTEM (July 9, 2002)
  • K010950 — CYPRESS SYSTEM (June 27, 2001)
  • K002807 — 3D ORGAN ASSESSMENT W/ MAGNETIC POSITION SENSING (December 1, 2000)
  • K992631 — ACUNAV DIAGNOSTIC ULTRASOUND CATHETER (December 15, 1999)
  • K992580 — FETAL ASSESSMENT CAP (October 18, 1999)
  • K991805 — ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION (August 2, 1999)
  • K973767 — HARMONIC IMAGING WITH CONTRAST (December 23, 1997)

Other clearances for product code DQC

  • K950537 — CARDIOPHONICS INCORPORATED DPS 2000 PHONOCARDIOGRAPH (March 1, 1996)
  • K952651 — LIFE SOUND SENSOR (September 19, 1995)
  • K943726 — ACOUSTIC RECORDER (November 30, 1994)
  • K924054 — PHONOCARDIOGRAPH (January 22, 1993)
  • K902185 — DYNAMIC SPECTRAL PHONOCARDIOGRAPH (March 25, 1991)
  • K900365 — PAG MICROPROCESSOR-CONTROLLED MODULE (July 18, 1990)
  • K873640 — MODIFIED DSP100 AMPLIFIER (December 7, 1987)
  • K870545 — ANDRIES PHYSICAL ASSESSMENT COMPUTER (August 14, 1987)
  • K864429 — DSP100 CAROTID PHONOANGIOGRAPHY MODULE (May 12, 1987)
  • K860814 — DSP100 AMPLIFIER (December 5, 1986)

FDA data resources