510(k) K881905

MODEL MICRO SI AMBULATORY ECG MONITOR by Advanced Medical Products, Inc. — Product Code DSI

K881905 is an FDA 510(k) premarket notification submitted by Advanced Medical Products, Inc. for the device "MODEL MICRO SI AMBULATORY ECG MONITOR". The FDA issued a decision of Substantially Equivalent on August 2, 1988. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. Advanced Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1988
Date Received
May 6, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detector And Alarm, Arrhythmia
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type