510(k) K974561

MOISTAIR FLUID AIR TUBING SET by American Medical Devices, Inc. — Product Code KYG

K974561 is an FDA 510(k) premarket notification submitted by American Medical Devices, Inc. for the device "MOISTAIR FLUID AIR TUBING SET". The FDA issued a decision of Substantially Equivalent on February 19, 1998. The device falls under product code KYG (Device, Irrigation, Ocular Surgery), a Class I device regulated under 21 CFR 886.4360. American Medical Devices, Inc. has at least 5 other 510(k) clearances on record.