FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARDIO 7
K Number: K113306
·
Decision Jul 16, 2012
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
574
Applicant Total
11
Review Days
250
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Basic Information
- Device Name
- CARDIO 7
- K Number
- K113306
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bionet Co., Ltd.
- Date Received
- November 9, 2011
- Decision Date
- July 16, 2012
- Product Code
- DPS
- 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 |
|---|---|---|---|
| DPS | Electrocardiograph | FDA class 2 | Cardiovascular |
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