510(k) K944337

VARIOUS STETHOSCOPES by Rud Riester GmbH & CO KG — Product Code LDE

K944337 is an FDA 510(k) premarket notification submitted by Rud Riester GmbH & CO KG for the device "VARIOUS STETHOSCOPES". The FDA issued a decision of Substantially Equivalent on November 30, 1994. The device falls under product code LDE (Stethoscope, Manual), a Class I device regulated under 21 CFR 870.1875. Rud Riester GmbH & CO KG has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 1994
Date Received
September 6, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stethoscope, Manual
Device Class
Class I
Regulation Number
870.1875
Review Panel
CV
Submission Type