FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
CARDIOVIT FT-1
K Number: K170182
·
Decision Jul 19, 2017
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
570
Applicant Total
15
Review Days
177
Basic Information
- Device Name
- CARDIOVIT FT-1
- K Number
- K170182
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SCHILLER AG
- Date Received
- January 23, 2017
- Decision Date
- July 19, 2017
- 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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