FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Freespira
K Number: K180173
·
Decision Aug 23, 2018
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
171
Applicant Total
1
Review Days
213
Basic Information
- Device Name
- Freespira
- K Number
- K180173
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5050
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Palo Alto Health Sciences, Inc.
- Date Received
- January 22, 2018
- Decision Date
- August 23, 2018
- Product Code
- HCC
- 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 |
|---|---|---|---|
| HCC | Device, Biofeedback | FDA class 2 | Neurology |
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