510(k) K895895

MODEL 219 TELEMETRY SYSTEM by Mennen Medical, Inc. — Product Code GYE

K895895 is an FDA 510(k) premarket notification submitted by Mennen Medical, Inc. for the device "MODEL 219 TELEMETRY SYSTEM". The FDA issued a decision of Substantially Equivalent on February 22, 1990. The device falls under product code GYE (Encephalogram Telemetry System), a Class II device regulated under 21 CFR 882.1855. Mennen Medical, Inc. has at least 10 other 510(k) clearances on record.