FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENSITE VELOCITY SYSTEM
K Number: K130594
·
Decision May 3, 2013
Classifications
1
FEI Numbers
170
Registration Numbers
170
Same Product Code
403
Applicant Total
93
Review Days
57
Basic Information
- Device Name
- ENSITE VELOCITY SYSTEM
- K Number
- K130594
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1425
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ST. JUDE MEDICAL
- Date Received
- March 7, 2013
- Decision Date
- May 3, 2013
- Product Code
- DQK
- 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 |
|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | FDA class 2 | Cardiovascular |
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