510(k) K854065

INFANT LIFE SUPPORT MODULE-20 by Intl. Biomedics, Inc. — Product Code FPL

K854065 is an FDA 510(k) premarket notification submitted by Intl. Biomedics, Inc. for the device "INFANT LIFE SUPPORT MODULE-20". The FDA issued a decision of Substantially Equivalent on January 16, 1986. The device falls under product code FPL (Incubator, Neonatal Transport), a Class II device regulated under 21 CFR 880.5410. Intl. Biomedics, Inc. has at least 1 other 510(k) clearance on record.