510(k) K971670

3 CHANNEL DIGITAL AMBULATORY ECG RECORDER by Galix Biomedical Instrumentation, Inc. — Product Code DSH

K971670 is an FDA 510(k) premarket notification submitted by Galix Biomedical Instrumentation, Inc. for the device "3 CHANNEL DIGITAL AMBULATORY ECG RECORDER". The FDA issued a decision of Substantially Equivalent on January 29, 1998. The device falls under product code DSH (Recorder, Magnetic Tape, Medical), a Class II device regulated under 21 CFR 870.2800. Galix Biomedical Instrumentation, Inc. has at least 5 other 510(k) clearances on record.