PHONOCARDIOGRAPH— 510(k) K924054

Substantially Equivalent

Echo Ultrasound

FDA 510(k) clearance K924054 for PHONOCARDIOGRAPH, Substantially Equivalent on 1993-01-22. Applicant: Echo Ultrasound. Device class: 1.

Clearance details

Applicant: Echo Ultrasound
Product code: Code DQC
Device class: Class 1
Regulation: 21 CFR 870.2390
Advisory panel: Cardiovascular
Date received: 1992-08-12
Decision date: 1993-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Reedsville, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DQC

K950537 — CARDIOPHONICS INCORPORATED DPS 2000 PHONOCARDIOGRAPH1996-03-01
K952651 — LIFE SOUND SENSOR1995-09-19
K943726 — ACOUSTIC RECORDER1994-11-30
K902185 — DYNAMIC SPECTRAL PHONOCARDIOGRAPH1991-03-25
K900560 — ACUSON HEARTSOUND/PULSE/RESPIRATION MODULE1990-12-03

More clearances from Echo Ultrasound

K903414 — TRANSESOPHAGEAL PROBE HOLDER & DISINFECTING COLUMN1990-09-19
K893225 — COUPLANT WARMING DEVICE1989-10-12
K872519 — STERILIZED OMNI GEL1987-08-03
K844034 — SONOCARE1985-01-23
K844120 — ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS1985-01-23

Data sourced from openFDA. This site is unofficial and independent of the FDA.