FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
Serena Sleep Night Guard
K Number: K230495
·
Decision Oct 13, 2023
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
70
Applicant Total
2
Review Days
232
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Basic Information
- Device Name
- Serena Sleep Night Guard
- K Number
- K230495
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Meris Investment Group
- Date Received
- February 23, 2023
- Decision Date
- October 13, 2023
- Product Code
- MQC
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| MQC | Mouthguard, Prescription | FDA unclassified | Unknown |
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Other Clearances by Meris Investment Group
| K Number | Device Name | ||
|---|---|---|---|
| K203606 | Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA) | Mar 10, 2021 | Substantially Equivalent |