FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EnSite X EP System
K Number: K251234
·
Decision Jul 30, 2025
Classifications
1
FEI Numbers
178
Registration Numbers
178
Same Product Code
429
Applicant Total
57
Review Days
99
Basic Information
- Device Name
- EnSite X EP System
- K Number
- K251234
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1425
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ABBOTT MEDICAL
- Date Received
- April 22, 2025
- Decision Date
- July 30, 2025
- 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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