Cleared Traditional

K944337 - VARIOUS STETHOSCOPES (FDA 510(k) Clearance)

K944337 · Rud Riester GmbH & CO KG · Cardiovascular device

Nov 1994

Decision

85d

Days

Class 1

Risk

K944337 is an FDA 510(k) clearance for the VARIOUS STETHOSCOPES. This device is classified as a Stethoscope, Manual (Class I - General Controls, product code LDE).

Submitted by Rud Riester GmbH & CO KG (Jungingen, DE). The FDA issued a Cleared decision on November 30, 1994, 85 days after receiving the submission on September 6, 1994.

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

Submission Details

510(k) Number	K944337 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 06, 1994
Decision Date	November 30, 1994
Days to Decision	85 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Statement