510(k) K053564

KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454 by Penlon Limited — Product Code CAD

K053564 is an FDA 510(k) premarket notification submitted by Penlon Limited for the device "KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454". The FDA issued a decision of Substantially Equivalent on March 3, 2006. The device falls under product code CAD (Vaporizer, Anesthesia, Non-Heated), a Class II device regulated under 21 CFR 868.5880. Penlon Limited has at least 2 other 510(k) clearances on record.