510(k) K060321

ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK by American Diagnostic Corp. — Product Code DQD

K060321 is an FDA 510(k) premarket notification submitted by American Diagnostic Corp. for the device "ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK". The FDA issued a decision of Substantially Equivalent on May 15, 2006. The device falls under product code DQD (Stethoscope, Electronic), a Class II device regulated under 21 CFR 870.1875. American Diagnostic Corp. has at least 10 other 510(k) clearances on record.