510(k) K820459

VIRAGARD/VIRASHIELD by Tri-Med, Inc. — Product Code DRS

K820459 is an FDA 510(k) premarket notification submitted by Tri-Med, Inc. for the device "VIRAGARD/VIRASHIELD". The FDA issued a decision of Substantially Equivalent on Jun 16, 1982. The device falls under product code DRS (Transducer, Blood-Pressure, Extravascular), a Class II device regulated under 21 CFR 870.2850. Tri-Med, Inc. has at least 10 other 510(k) clearances on record.