510(k) K023494

NELLCOR INDGO MANUAL RESUSCITATOR by Nellcor Puritan Bennett, Inc. — Product Code BTM

K023494 is an FDA 510(k) premarket notification submitted by Nellcor Puritan Bennett, Inc. for the device "NELLCOR INDGO MANUAL RESUSCITATOR". The FDA issued a decision of Substantially Equivalent on February 7, 2003. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915. Nellcor Puritan Bennett, Inc. has at least 10 other 510(k) clearances on record.