FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
CARDIOVIT AT-102
K Number: K031557
·
Decision Apr 14, 2004
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
570
Applicant Total
15
Review Days
331
Basic Information
- Device Name
- CARDIOVIT AT-102
- K Number
- K031557
- 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
- May 19, 2003
- Decision Date
- April 14, 2004
- 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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