510(k) K971601

OLYMPIC BILI-BASSINET by Olympic Medical Corp. — Product Code LBI

K971601 is an FDA 510(k) premarket notification submitted by Olympic Medical Corp. for the device "OLYMPIC BILI-BASSINET". The FDA issued a decision of Substantially Equivalent on September 24, 1997. The device falls under product code LBI (Unit, Neonatal Phototherapy), a Class II device regulated under 21 CFR 880.5700. Olympic Medical Corp. has at least 10 other 510(k) clearances on record.