510(k) K111515

SPSMEDICAL SPORVIEW STEAM BI by Spsmedical Supply Corp. — Product Code FRC

K111515 is an FDA 510(k) premarket notification submitted by Spsmedical Supply Corp. for the device "SPSMEDICAL SPORVIEW STEAM BI". The FDA issued a decision of Substantially Equivalent on February 1, 2012. The device falls under product code FRC (Indicator, Biological Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Spsmedical Supply Corp. has at least 10 other 510(k) clearances on record.