510(k) K021622

HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103 by Hill-Rom Air-Shields — Product Code MQM

K021622 is an FDA 510(k) premarket notification submitted by Hill-Rom Air-Shields for the device "HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103". The FDA issued a decision of Substantially Equivalent on April 1, 2003. The device falls under product code MQM (Bilirubin (Total And Unbound) In The Neonate Test System), a Class I device regulated under 21 CFR 862.1113. Hill-Rom Air-Shields has at least 4 other 510(k) clearances on record.