FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Cadwell Guardian
K Number: K230415
·
Decision Aug 17, 2023
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
138
Applicant Total
12
Review Days
182
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Basic Information
- Device Name
- Cadwell Guardian
- K Number
- K230415
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1870
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cadwell Industries, Inc.
- Date Received
- February 16, 2023
- Decision Date
- August 17, 2023
- 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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