510(k) K022876

MODIFICATION TO INFANT LIFE SUPPORT MODULE-20 by International Biomedical, Inc. — Product Code FPL

K022876 is an FDA 510(k) premarket notification submitted by International Biomedical, Inc. for the device "MODIFICATION TO INFANT LIFE SUPPORT MODULE-20". The FDA issued a decision of Substantially Equivalent on September 11, 2002. The device falls under product code FPL (Incubator, Neonatal Transport), a Class II device regulated under 21 CFR 880.5410. International Biomedical, Inc. has at least 10 other 510(k) clearances on record.