Iai Program-Computer Program

FDA 510(k) K844997 · Intl. Acoustics, Inc.

Substantially Equivalent

510(k) numberK844997

Submission

Device name
Iai Program-Computer Program
Applicant
Intl. Acoustics, Inc.
Palatine, IL, US
Received
December 26, 1984
Decision date
April 9, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DXG – Computer, Diagnostic, Pre-Programmed, Single-Function
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1435
Specialty
Cardiovascular

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More from Lidco, Ltd.

510(k)DeviceDecision
K873640Modified DSP100 AmplifierDQC · Traditional 12/07/1987SE
K864278Ds-Ii Digital Sonography SystemDQD · Traditional 06/10/1987SE
K864429DSP100 Carotid Phonoangiography ModuleDQC · Traditional 05/12/1987SE
K860814DSP100 AmplifierDQC · Traditional 12/05/1986SE

Questions and answers

When was Iai Program-Computer Program cleared by the FDA?

Iai Program-Computer Program (K844997) received a 510(k) decision of Substantially Equivalent on April 9, 1985, 104 days after the submission was received.

What is the product code of K844997?

The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.