FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
MODIFICATION TO GLOBALCARDIO
K Number: K033037
·
Decision Oct 31, 2003
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
190
Applicant Total
6
Review Days
32
Basic Information
- Device Name
- MODIFICATION TO GLOBALCARDIO
- K Number
- K033037
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CARDIOCOMM SOLUTIONS, INC.
- Date Received
- September 29, 2003
- Decision Date
- October 31, 2003
- Product Code
- DSH
- 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 |
|---|---|---|---|
| DSH | Recorder, Magnetic Tape, Medical | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DSH), ordered by most recent decision date.
AeviceMD
FDA 510(k)
FDA Class 2
·Cardiovascular
AT-Patch (ATP-C130/ATP-C70)
FDA 510(k)
FDA Class 2
·Cardiovascular
HiCardi+ H100
FDA 510(k)
FDA Class 2
·Cardiovascular
S-Patch (S-Patch ExL)
FDA 510(k)
FDA Class 2
·Cardiovascular
ABPMpro
FDA 510(k)
FDA Class 2
·Cardiovascular
Carnation Ambulatory Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by CARDIOCOMM SOLUTIONS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K122632 | GUAVA II | Feb 11, 2014 | Substantially Equivalent |
| K111320 | GLOBALCARDIO | Oct 7, 2011 | 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 |