Cardiosonic Acoustic Amplifier

FDA 510(k) K813510 · Srs Co.

Substantially Equivalent

510(k) numberK813510

Submission

Device name
Cardiosonic Acoustic Amplifier
Applicant
Srs Co.
Mchenry, IL, US
Received
December 15, 1981
Decision date
January 12, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LDE – Stethoscope, Manual
Device class
Class I (low risk)
Regulation
21 CFR 870.1875
Specialty
Cardiovascular

Other 510(k)s with product code LDE

510(k)DeviceApplicantDecision
K945082Cypress Medical Products StethoscopeLDE · Traditional Cypress Medical Products, Ltd.12/08/1994SE
K944337Various StethoscopesLDE · Traditional Rud Riester GmbH & CO KG11/30/1994SE
K940578Manual StetoscopeLDE · Traditional Bhs Intl., Inc.04/26/1994SE
K935944Proscopes and AdscopesLDE · Traditional American Diagnostic Corp.03/03/1994SE
K923327Stethoscope CoverLDE · Traditional Anup Chakraborty Co.11/03/1992SE
K924095Timeoscope and FlexiscopeLDE · Traditional Stethoscopes of America, Inc.10/20/1992SE
K914100StethoscopeLDE · Traditional Atlas Medical Products, Inc.11/07/1991SE
K912128Maxi-Scope or Ultra-ScopeLDE · Traditional Seiichi Mfg., Inc.06/28/1991SE
K905487Various Types of StethoscopesLDE · Traditional Liaoning-Usa Corp.04/09/1991SE
K904547StethoscopeLDE · Traditional Kimball Industries Co., Ltd.03/21/1991SE

More from Kimball Industries Co., Ltd.

510(k)DeviceDecision
K823381Professional Mark I Biofeedback SysHCC · Traditional 01/05/1983SE

Questions and answers

When was Cardiosonic Acoustic Amplifier cleared by the FDA?

Cardiosonic Acoustic Amplifier (K813510) received a 510(k) decision of Substantially Equivalent on January 12, 1982, 28 days after the submission was received.

What is the product code of K813510?

The FDA product code is LDE – Stethoscope, Manual, a Class I (low risk) device regulated under 21 CFR 870.1875.