Cleared Traditional

K940578 - MANUAL STETOSCOPE
(FDA 510(k) Clearance)

K940578 · Bhs Intl., Inc. · Cardiovascular device

Apr 1994

Decision

77d

Days

Class 1

Risk

K940578 is an FDA 510(k) clearance for the MANUAL STETOSCOPE. This device is classified as a Stethoscope, Manual (Class I - General Controls, product code LDE).

Submitted by Bhs Intl., Inc. (Crofton, US). The FDA issued a Cleared decision on April 26, 1994, 77 days after receiving the submission on February 8, 1994.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1875.

Submission Details

510(k) Number	K940578 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 08, 1994
Decision Date	April 26, 1994
Days to Decision	77 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Statement