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Cardiocomm Solutions, Inc.

FDA Regulatory Profile

Cardiocomm Solutions, Inc. has 0 FDA recalls, 0 inspections, 9 510(k) clearances and 0 compliance actions on record.

Latest 510(k)
Feb 22, 2019

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances9Oct 4, 2026Not statedCurrent
Inspections0Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent 510(k) Clearances

K-NumberDeviceDate
K181310HeartCheck Cardi Beat ECG Monitor with GEMS MobileFeb 22, 2019
K122632GUAVA IIFeb 11, 2014
K121009HEARTCHECK ECG PEN WITH GEMS HOMEMay 17, 2012
K111159HEARTCHECK PEN HANDHELD ECG WITH GEMS HOMEDec 22, 2011
K111320GLOBALCARDIOOct 7, 2011
K033037MODIFICATION TO GLOBALCARDIOOct 31, 2003
K022297GLOBAL ECG MANAGEMENT SYSTEM (GEMS)Sep 27, 2002
K020366GLOBAL ECG MANAGEMENT SYSTEM (GEMS)Apr 30, 2002
K013354GLOBALCARDIOJan 31, 2002

FDA data resources