DSP100 Carotid Phonoangiography Module

FDA 510(k) K864429 · Intl. Acoustics, Inc.

Substantially Equivalent

510(k) numberK864429

Submission

Device name
DSP100 Carotid Phonoangiography Module
Applicant
Intl. Acoustics, Inc.
Palatine, IL, US
Received
November 12, 1986
Decision date
May 12, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DQC – Phonocardiograph
Device class
Class I (low risk)
Regulation
21 CFR 870.2390
Specialty
Cardiovascular

Other 510(k)s with product code DQC

510(k)DeviceApplicantDecision
K950537Cardiophonics Incorporated DPS 2000 PhonocardiographDQC · Traditional Cardiophonics, Inc.03/01/1996SE
K952651Life Sound SensorDQC · Traditional Flowscan, Inc.09/19/1995SE
K943726Acoustic RecorderDQC · Traditional Technology Applications Assoc., Inc.11/30/1994SE
K924054PhonocardiographDQC · Traditional Echo Ultrasound01/22/1993SE
K902185Dynamic Spectral PhonocardiographDQC · Traditional Reeves Scientific, Inc.03/25/1991SE
K900560Acuson Heartsound/Pulse/Respiration ModuleDQC · Traditional Acuson Corp.12/03/1990SE
K900365Pag Microprocessor-Controlled ModuleDQC · Traditional Life Sciences Manufacturing, Inc.07/18/1990SE
K873640Modified DSP100 AmplifierDQC · Traditional Intl. Acoustics, Inc.12/07/1987SE
K870545Andries Physical Assessment ComputerDQC · Traditional Andries Tek, Inc.08/14/1987SE
K860814DSP100 AmplifierDQC · Traditional Intl. Acoustics, Inc.12/05/1986SE

More from Intl. Acoustics, Inc.

510(k)DeviceDecision
K873640Modified DSP100 AmplifierDQC · Traditional 12/07/1987SE
K864278Ds-Ii Digital Sonography SystemDQD · Traditional 06/10/1987SE
K860814DSP100 AmplifierDQC · Traditional 12/05/1986SE
K844997Iai Program-Computer ProgramDXG · Traditional 04/09/1985SE

Questions and answers

When was DSP100 Carotid Phonoangiography Module cleared by the FDA?

DSP100 Carotid Phonoangiography Module (K864429) received a 510(k) decision of Substantially Equivalent on May 12, 1987, 181 days after the submission was received.

What is the product code of K864429?

The FDA product code is DQC – Phonocardiograph, a Class I (low risk) device regulated under 21 CFR 870.2390.