510(k) K092029

VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310 by Draeger Medical AG & Co. KG — Product Code BYE

K092029 is an FDA 510(k) premarket notification submitted by Draeger Medical AG & Co. KG for the device "VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310". The FDA issued a decision of Substantially Equivalent on August 6, 2010. The device falls under product code BYE (Attachment, Breathing, Positive End Expiratory Pressure), a Class II device regulated under 21 CFR 868.5965. Draeger Medical AG & Co. KG has at least 9 other 510(k) clearances on record.