FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
HeartCheck Cardi Beat ECG Monitor with GEMS Mobile
K Number: K181310
·
Decision Feb 22, 2019
Classifications
1
FEI Numbers
80
Registration Numbers
80
Same Product Code
296
Applicant Total
9
Review Days
281
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Basic Information
- Device Name
- HeartCheck Cardi Beat ECG Monitor with GEMS Mobile
- K Number
- K181310
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2920
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cardiocomm Solutions, Inc.
- Date Received
- May 17, 2018
- Decision Date
- February 22, 2019
- Product Code
- DXH
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | FDA class 2 | Cardiovascular |
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Other Clearances by Cardiocomm Solutions, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K122632 | GUAVA II | Feb 11, 2014 | Substantially Equivalent |
| K121009 | HEARTCHECK ECG PEN WITH GEMS HOME | May 17, 2012 | Substantially Equivalent |
| K111159 | HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME | Dec 22, 2011 | Substantially Equivalent |
| K111320 | GLOBALCARDIO | Oct 7, 2011 | Substantially Equivalent |
| K033037 | MODIFICATION TO GLOBALCARDIO | Oct 31, 2003 | Substantially Equivalent |
| K022297 | GLOBAL ECG MANAGEMENT SYSTEM (GEMS) | Sep 27, 2002 | Substantially Equivalent |
| K020366 | GLOBAL ECG MANAGEMENT SYSTEM (GEMS) | Apr 30, 2002 | Substantially Equivalent |
| K013354 | GLOBALCARDIO | Jan 31, 2002 | Substantially Equivalent |