510(k) K954216

OLYMPIC WARM-BASSINET by Olympic Medical Corp. — Product Code FOH

K954216 is an FDA 510(k) premarket notification submitted by Olympic Medical Corp. for the device "OLYMPIC WARM-BASSINET". The FDA issued a decision of Substantially Equivalent on December 8, 1995. The device falls under product code FOH (Mattress, Water, Temperature Regulated), a Class I device regulated under 21 CFR 880.5560. Olympic Medical Corp. has at least 10 other 510(k) clearances on record.