510(k) K831460

AS 30/TCP MODULE by Narco Scientific — Product Code KLK

K831460 is an FDA 510(k) premarket notification submitted by Narco Scientific for the device "AS 30/TCP MODULE". The FDA issued a decision of Substantially Equivalent on July 12, 1983. The device falls under product code KLK (Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia), a Class II device regulated under 21 CFR 868.2500. Narco Scientific has at least 10 other 510(k) clearances on record.