FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
CV3000 HOLTER ANALYSIS SYSTEM
K Number: K131897
·
Decision Nov 26, 2013
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
31
Applicant Total
2
Review Days
154
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Basic Information
- Device Name
- CV3000 HOLTER ANALYSIS SYSTEM
- K Number
- K131897
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vales & Hills Biomedical Tech. , Ltd.
- Date Received
- June 25, 2013
- Decision Date
- November 26, 2013
- Product Code
- MLO
- 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 |
|---|---|---|---|
| MLO | Electrocardiograph, Ambulatory, With Analysis Algorithm | FDA class 2 | Cardiovascular |
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Other Clearances by Vales & Hills Biomedical Tech. , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K163607 | ECG Acquisition Systems | Dec 15, 2017 | Substantially Equivalent |