510(k) K842349

AMBULATORY PH RECORDING DEVICE by Clinical Data Instruments, Inc. — Product Code DSH

K842349 is an FDA 510(k) premarket notification submitted by Clinical Data Instruments, Inc. for the device "AMBULATORY PH RECORDING DEVICE". The FDA issued a decision of Substantially Equivalent on June 14, 1985. The device falls under product code DSH (Recorder, Magnetic Tape, Medical), a Class II device regulated under 21 CFR 870.2800. Clinical Data Instruments, Inc. has at least 2 other 510(k) clearances on record.