510(k) K972158

GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES by Princeton Regulatory Assoc. — Product Code MEB

K972158 is an FDA 510(k) premarket notification submitted by Princeton Regulatory Assoc. for the device "GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES". The FDA issued a decision of Substantially Equivalent on February 20, 1998. The device falls under product code MEB (Pump, Infusion, Elastomeric), a Class II device regulated under 21 CFR 880.5725. Princeton Regulatory Assoc. has at least 3 other 510(k) clearances on record.