Manual Stetoscope

FDA 510(k) K940578 · Bhs Intl., Inc.

Substantially Equivalent

510(k) numberK940578

Submission

Device name
Manual Stetoscope
Applicant
Bhs Intl., Inc.
Crofton, MD, US
Received
February 8, 1994
Decision date
April 26, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

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
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
K895545V*S*R(Tm) ScopeLDE · Traditional Vsr Enterprises Corp.11/15/1989SE

More from Vsr Enterprises Corp.

510(k)DeviceDecision
K000814Finger Pulse MeterDQA · Traditional 03/29/2001SE

Questions and answers

When was Manual Stetoscope cleared by the FDA?

Manual Stetoscope (K940578) received a 510(k) decision of Substantially Equivalent on April 26, 1994, 77 days after the submission was received.

What is the product code of K940578?

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