FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
The EPAD 2 System
K Number: K182542
·
Decision Feb 22, 2019
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
137
Applicant Total
1
Review Days
158
Basic Information
- Device Name
- The EPAD 2 System
- K Number
- K182542
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1870
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SafeOp Surgical, Inc.
- Date Received
- September 17, 2018
- Decision Date
- February 22, 2019
- Product Code
- GWF
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GWF | Stimulator, Electrical, Evoked Response | FDA class 2 | Neurology |
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