FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Espire Elbow Pro, Espire Elbow Hybrid
K Number: K182757
·
Decision Nov 29, 2018
Classifications
1
FEI Numbers
243
Registration Numbers
243
Same Product Code
436
Applicant Total
1
Review Days
62
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Basic Information
- Device Name
- Espire Elbow Pro, Espire Elbow Hybrid
- K Number
- K182757
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1320
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- College Park Industries, Inc.
- Date Received
- September 28, 2018
- Decision Date
- November 29, 2018
- Product Code
- GXY
- 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 |
|---|---|---|---|
| GXY | Electrode, Cutaneous | FDA class 2 | Neurology |
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