FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
BODY SIGNAL ECG ELECTRODE
K Number: K031174
·
Decision Jul 10, 2003
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
328
Applicant Total
4
Review Days
87
Basic Information
- Device Name
- BODY SIGNAL ECG ELECTRODE
- K Number
- K031174
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2360
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- WANDY RUBBER INDUSTRIAL CO., LTD
- Date Received
- April 14, 2003
- Decision Date
- July 10, 2003
- Product Code
- DRX
- 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 |
|---|---|---|---|
| DRX | Electrode, Electrocardiograph | FDA class 2 | Cardiovascular |
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