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510(k) K924054

PHONOCARDIOGRAPH by Echo Ultrasound — Product Code DQC

K924054 is an FDA 510(k) premarket notification submitted by Echo Ultrasound for the device "PHONOCARDIOGRAPH". The FDA issued a decision of Substantially Equivalent on January 22, 1993. The device falls under product code DQC (Phonocardiograph), a Class I device regulated under 21 CFR 870.2390. Echo Ultrasound has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1993
Date Received
August 12, 1992
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 Echo Ultrasound

  • K903414 — TRANSESOPHAGEAL PROBE HOLDER & DISINFECTING COLUMN (September 19, 1990)
  • 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 DQC

  • K950537 — CARDIOPHONICS INCORPORATED DPS 2000 PHONOCARDIOGRAPH (March 1, 1996)
  • K952651 — LIFE SOUND SENSOR (September 19, 1995)
  • K943726 — ACOUSTIC RECORDER (November 30, 1994)
  • K902185 — DYNAMIC SPECTRAL PHONOCARDIOGRAPH (March 25, 1991)
  • K900560 — ACUSON HEARTSOUND/PULSE/RESPIRATION MODULE (December 3, 1990)
  • 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