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510(k) K924054

Device
PHONOCARDIOGRAPH
Applicant
ECHO ULTRASOUND
510(k) number
K924054
Product code
DQC  
Decision
Substantially Equivalent (SESE)
Decision date
1993-01-22
Date received
1992-08-12
Regulation
870.2390
Classification name
Phonocardiograph
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
RUSSELL W WOODS
Address
R.D. 2, Box 118 Reedsville PA US 17084 17084

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DQC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K950537CARDIOPHONICS INCORPORATED DPS 2000 PHONOCARDIOGRAPHCardiophonics, Inc.1996-03-01
K952651LIFE SOUND SENSORFlowscan, Inc.1995-09-19
K943726ACOUSTIC RECORDERTechnology Applications Assoc., Inc.1994-11-30
K902185DYNAMIC SPECTRAL PHONOCARDIOGRAPHReeves Scientific, Inc.1991-03-25
K900560ACUSON HEARTSOUND/PULSE/RESPIRATION MODULEAcuson Corp.1990-12-03
K900365PAG MICROPROCESSOR-CONTROLLED MODULELife Sciences Manufacturing, Inc.1990-07-18
K873640MODIFIED DSP100 AMPLIFIERIntl. Acoustics, Inc.1987-12-07
K870545ANDRIES PHYSICAL ASSESSMENT COMPUTERAndries Tek, Inc.1987-08-14
K864429DSP100 CAROTID PHONOANGIOGRAPHY MODULEIntl. Acoustics, Inc.1987-05-12
K860814DSP100 AMPLIFIERIntl. Acoustics, Inc.1986-12-05
K811626MEDDARS/ULTRA IMAGER PULSE/PHON MODULEHoneywell, Inc.1981-07-01
K800655MODEL 100 SPECTRAVIEWEdwards Laboratories1980-04-16
K792466NIC-200 VENTRICULAR FUNCTION ANALYZERNicolet Biomedical Instruments1980-01-24
K780116AMPLIFIER, PC-700Burdick Corp.1978-02-24
K770757PULSE/PHONOCARDIOGRAPHY CHANNEL, 144Honeywell, Inc.1977-05-09

Legacy Summary#

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FDA Review#

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