The following data is part of a premarket notification filed by Applied Cardiac Systems, Inc. with the FDA for The Core (cardiac Outpatient Realtime Ecg) Monitor.
Device ID | K103706 |
510k Number | K103706 |
Device Name: | THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR |
Classification | Detector And Alarm, Arrhythmia |
Applicant | APPLIED CARDIAC SYSTEMS, INC. 22912 El Pacifico Dr Laguna Hills, CA 92653 |
Contact | R. Ben Ghadimi |
Correspondent | R. Ben Ghadimi APPLIED CARDIAC SYSTEMS, INC. 22912 El Pacifico Dr Laguna Hills, CA 92653 |
Product Code | DSI |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-12-20 |
Decision Date | 2011-08-24 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00853512007001 | K103706 | 000 |