510(k) K872508

MODEL MICRO FD+ AMBULATORY ECG MONITOR by Advanced Medical Products, Inc. — Product Code DSH

K872508 is an FDA 510(k) premarket notification submitted by Advanced Medical Products, Inc. for the device "MODEL MICRO FD+ AMBULATORY ECG MONITOR". The FDA issued a decision of Substantially Equivalent on September 25, 1987. The device falls under product code DSH (Recorder, Magnetic Tape, Medical), a Class II device regulated under 21 CFR 870.2800. Advanced Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1987
Date Received
June 24, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Recorder, Magnetic Tape, Medical
Device Class
Class II
Regulation Number
870.2800
Review Panel
CV
Submission Type