SIMULSCOPE AUSCULTATION AND SIMULSCOPE BEDSIDE AUSCULTATION SYSTEM

SIMULSCOPE AUSCULTATION AND SIMULSCOPE BEDSIDE AUSCULTATION SYSTEM is an FDA 510(k)-cleared medical device (K961937) manufactured by Delphi Consulting Group. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 8, 1996. Regulation: 8.