510(k) K945826

J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONS by Medical Device Inspection Co., Inc. — Product Code HCC

K945826 is an FDA 510(k) premarket notification submitted by Medical Device Inspection Co., Inc. for the device "J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONS". The FDA issued a decision of Substantially Equivalent on August 4, 1995. The device falls under product code HCC (Device, Biofeedback), a Class II device regulated under 21 CFR 882.5050. Medical Device Inspection Co., Inc. has at least 10 other 510(k) clearances on record.