510(k) K911615

HOLTER 24-HOUR ECG SYSTEM, MODEL NUMBER: DMS 300 by Diagnostic Monitoring Software — Product Code DQK

K911615 is an FDA 510(k) premarket notification submitted by Diagnostic Monitoring Software for the device "HOLTER 24-HOUR ECG SYSTEM, MODEL NUMBER: DMS 300". The FDA issued a decision of Substantially Equivalent on January 8, 1992. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Diagnostic Monitoring Software has at least 4 other 510(k) clearances on record.