Ds-Ii Digital Sonography System

FDA 510(k) K864278 · Intl. Acoustics, Inc.

Substantially Equivalent

510(k) numberK864278

Submission

Device name
Ds-Ii Digital Sonography System
Applicant
Intl. Acoustics, Inc.
Palatine, IL, US
Received
October 30, 1986
Decision date
June 10, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DQD – Stethoscope, Electronic
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1875
Specialty
Cardiovascular

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K252284eMurmur Heart AIDQD · Traditional Csd Labs12/19/2025SE
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K251494Eko Foundation Analysis Software with Transformers (EFAST)DQD · Traditional Eko Health, Inc.08/12/2025SE
K242971AccurSound Electronic Stethoscope (AS101)DQD · Traditional Heroic Faith International , Ltd.11/25/2024SE
K240901StethophoneDQD · Traditional Sparrow Acoustics, Inc.09/19/2024SE

More from Sparrow Acoustics, Inc.

510(k)DeviceDecision
K873640Modified DSP100 AmplifierDQC · Traditional 12/07/1987SE
K864429DSP100 Carotid Phonoangiography ModuleDQC · Traditional 05/12/1987SE
K860814DSP100 AmplifierDQC · Traditional 12/05/1986SE
K844997Iai Program-Computer ProgramDXG · Traditional 04/09/1985SE

Questions and answers

When was Ds-Ii Digital Sonography System cleared by the FDA?

Ds-Ii Digital Sonography System (K864278) received a 510(k) decision of Substantially Equivalent on June 10, 1987, 223 days after the submission was received.

What is the product code of K864278?

The FDA product code is DQD – Stethoscope, Electronic, a Class II (moderate risk) device regulated under 21 CFR 870.1875.