510(k) K131558

PG-800B SERIES, INCLUDING PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3, PG-800B4, PG-800B4D, PG-800B5, PG-800B5-1, PG-800B6 by Shenzhen Pango Electronic Co., Ltd. — Product Code DXN

K131558 is an FDA 510(k) premarket notification submitted by Shenzhen Pango Electronic Co., Ltd. for the device "PG-800B SERIES, INCLUDING PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3, PG-800B4, PG-800B4D, PG-800B5, PG-800B5-1, PG-800B6". The FDA issued a decision of Substantially Equivalent on Aug 30, 2013. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Shenzhen Pango Electronic Co., Ltd. has 8 other 510(k) clearances on record.