510(k) K953620

WARM N WET HMEF W/LUER ADAPTER by Hospitak, Inc. — Product Code BYD

K953620 is an FDA 510(k) premarket notification submitted by Hospitak, Inc. for the device "WARM N WET HMEF W/LUER ADAPTER". The FDA issued a decision of Substantially Equivalent on August 25, 1995. The device falls under product code BYD (Condenser, Heat And Moisture (Artificial Nose)), a Class I device regulated under 21 CFR 868.5375. Hospitak, Inc. has at least 10 other 510(k) clearances on record.