FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)
K Number: K203606
·
Decision Mar 10, 2021
Classifications
1
FEI Numbers
105
Registration Numbers
105
Same Product Code
212
Applicant Total
2
Review Days
90
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Basic Information
- Device Name
- Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)
- K Number
- K203606
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5570
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Meris Investment Group
- Date Received
- December 10, 2020
- Decision Date
- March 10, 2021
- Product Code
- LRK
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| LRK | Device, Anti-Snoring | FDA class 2 | Dental |
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Other Clearances by Meris Investment Group
| K Number | Device Name | ||
|---|---|---|---|
| K230495 | Serena Sleep Night Guard | Oct 13, 2023 | Substantially Equivalent |