510(k) K122024

SPSMEDICAL SPORVIEW 10 STEAM SELF CONTAINED BIOLOGICAL INDICATOR by Spsmedical Supply Corp. — Product Code FRC

K122024 is an FDA 510(k) premarket notification submitted by Spsmedical Supply Corp. for the device "SPSMEDICAL SPORVIEW 10 STEAM SELF CONTAINED BIOLOGICAL INDICATOR". The FDA issued a decision of Substantially Equivalent on November 26, 2013. 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.