FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
Neurosplint
K Number: K143458
·
Decision Aug 13, 2015
Classifications
1
FEI Numbers
503
Registration Numbers
503
Same Product Code
51
Applicant Total
1
Review Days
252
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Basic Information
- Device Name
- Neurosplint
- K Number
- K143458
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3475
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Neurospectrum, LLC
- Date Received
- December 4, 2014
- Decision Date
- August 13, 2015
- Product Code
- IQI
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| IQI | Orthosis, Limb Brace | FDA class 1 | Physical Medicine |
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