FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ECG CHECK
K Number: K122184
·
Decision Feb 14, 2013
Classifications
1
FEI Numbers
80
Registration Numbers
80
Same Product Code
296
Applicant Total
2
Review Days
206
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Basic Information
- Device Name
- ECG CHECK
- K Number
- K122184
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2920
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cardiac Designs, LLC
- Date Received
- July 23, 2012
- Decision Date
- February 14, 2013
- 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 Cardiac Designs, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K131045 | ENTERPRISE ECG ANALYSIS / INTERPRETATION SOFTWARE | May 29, 2013 | Substantially Equivalent |