510(k) K780127

DINAMAP MODEL 850 by Applied Medical Research — Product Code DRS

K780127 is an FDA 510(k) premarket notification submitted by Applied Medical Research for the device "DINAMAP MODEL 850". The FDA issued a decision of Substantially Equivalent on January 31, 1978. The device falls under product code DRS (Transducer, Blood-Pressure, Extravascular), a Class II device regulated under 21 CFR 870.2850. Applied Medical Research has at least 10 other 510(k) clearances on record.