510(k) K103317

RESUSCITATION UNIT 105 by Atom Medical Corporation — Product Code BZR

K103317 is an FDA 510(k) premarket notification submitted by Atom Medical Corporation for the device "RESUSCITATION UNIT 105". The FDA issued a decision of Substantially Equivalent on April 20, 2011. The device falls under product code BZR (Mixer, Breathing Gases, Anesthesia Inhalation), a Class II device regulated under 21 CFR 868.5330. Atom Medical Corporation has at least 9 other 510(k) clearances on record.