510(k) K973613

CH-611B AND CH-611C DIGITAL WRIST SPHYGMOMANOMETERS BLOOD PRESSURE METER by Foley & Lardner — Product Code DXN

K973613 is an FDA 510(k) premarket notification submitted by Foley & Lardner for the device "CH-611B AND CH-611C DIGITAL WRIST SPHYGMOMANOMETERS BLOOD PRESSURE METER". The FDA issued a decision of Substantially Equivalent on April 14, 1998. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Foley & Lardner has at least 4 other 510(k) clearances on record.