FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
POSTURETEK
K Number: K093553
·
Decision Aug 13, 2010
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
4
Applicant Total
1
Review Days
269
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Basic Information
- Device Name
- POSTURETEK
- K Number
- K093553
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Perseus Althetics,Llc
- Date Received
- November 17, 2009
- Decision Date
- August 13, 2010
- Product Code
- LZW
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| LZW | Monitor, Spine Curvature | FDA unclassified | Unknown |
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