FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Talee, Talee PostOP
K Number: K220681
·
Decision Sep 22, 2022
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
42
Applicant Total
3
Review Days
198
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Basic Information
- Device Name
- Talee, Talee PostOP
- K Number
- K220681
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5970
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Invent Medical USA, LLC
- Date Received
- March 8, 2022
- Decision Date
- September 22, 2022
- Product Code
- MVA
- 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 |
|---|---|---|---|
| MVA | Orthosis, Cranial | FDA class 2 | Neurology |
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