510(k) K092809

HRV ACQUIRE by Wr Medical Electronics Co. — Product Code DRT

K092809 is an FDA 510(k) premarket notification submitted by Wr Medical Electronics Co. for the device "HRV ACQUIRE". The FDA issued a decision of Substantially Equivalent on October 19, 2010. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300. Wr Medical Electronics Co. has at least 5 other 510(k) clearances on record.