510(k) K831429

AS 191 ECG TELEMETRY MODULE by Narco Scientific — Product Code DPS

K831429 is an FDA 510(k) premarket notification submitted by Narco Scientific for the device "AS 191 ECG TELEMETRY MODULE". The FDA issued a decision of Substantially Equivalent on October 14, 1983. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Narco Scientific has at least 10 other 510(k) clearances on record.