510(k) K031647

BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR by Getinge USA, Inc. — Product Code JOJ

K031647 is an FDA 510(k) premarket notification submitted by Getinge USA, Inc. for the device "BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR". The FDA issued a decision of Substantially Equivalent on July 29, 2003. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Getinge USA, Inc. has at least 3 other 510(k) clearances on record.