Saltzman Stethoscope Head

FDA 510(k) K854771 · K & S Medicorp

Substantially Equivalent

510(k) numberK854771

Submission

Device name
Saltzman Stethoscope Head
Applicant
K & S Medicorp
Miami, FL, US
Received
November 29, 1985
Decision date
May 9, 1986
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
K862131Saltzman Ear(Tm) Endotracheal Ascultation ReceptorBZT · Traditional 07/14/1986SE
K854772Transcor (TM) Radio-StethoscopeDQD · Traditional 05/13/1986SE

Questions and answers

When was Saltzman Stethoscope Head cleared by the FDA?

Saltzman Stethoscope Head (K854771) received a 510(k) decision of Substantially Equivalent on May 9, 1986, 161 days after the submission was received.

What is the product code of K854771?

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