FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇬 Singapore
Hushd Pro Z-Link
K Number: K251784
·
Decision Oct 24, 2025
Classifications
1
FEI Numbers
105
Registration Numbers
105
Same Product Code
212
Applicant Total
3
Review Days
135
Basic Information
- Device Name
- Hushd Pro Z-Link
- K Number
- K251784
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5570
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Good Sleep CO Pte , Ltd.
- Date Received
- June 11, 2025
- Decision Date
- October 24, 2025
- 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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