510(k) K872517

TL 400 TOTALAB VASCULAR DIAGNOSTIC SYSTEM by D. E. Hokanson, Inc. — Product Code JOM

K872517 is an FDA 510(k) premarket notification submitted by D. E. Hokanson, Inc. for the device "TL 400 TOTALAB VASCULAR DIAGNOSTIC SYSTEM". The FDA issued a decision of Substantially Equivalent on October 1, 1987. The device falls under product code JOM (Plethysmograph, Photoelectric, Pneumatic Or Hydraulic), a Class II device regulated under 21 CFR 870.2780. D. E. Hokanson, Inc. has at least 10 other 510(k) clearances on record.