FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WINX SLEEP THERAPY SYSTEM
K Number: K130538
·
Decision May 22, 2013
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
5
Applicant Total
4
Review Days
82
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Basic Information
- Device Name
- WINX SLEEP THERAPY SYSTEM
- K Number
- K130538
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.5570
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Apnicure, Inc.
- Date Received
- March 1, 2013
- Decision Date
- May 22, 2013
- Product Code
- OZR
- Advisory Committee
- Dental
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| OZR | Intraoral Pressure Gradient Device | FDA class 2 | Dental |
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