FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ZQUIET PRO-PLUS
K Number: K122475
·
Decision Dec 7, 2012
Classifications
1
FEI Numbers
105
Registration Numbers
105
Same Product Code
212
Applicant Total
6
Review Days
115
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Basic Information
- Device Name
- ZQUIET PRO-PLUS
- K Number
- K122475
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5570
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sleeping Well, LLC
- Date Received
- August 14, 2012
- Decision Date
- December 7, 2012
- 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 Sleeping Well, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K213088 | ZQuiet Advance | Jun 15, 2022 | Substantially Equivalent |
| K180124 | ZQuiet | Jun 12, 2018 | Substantially Equivalent |
| K140777 | ZQUIET-SA | Jul 25, 2014 | Substantially Equivalent |
| K093407 | ZQUIET MOUTHPIECE | Jun 22, 2010 | Substantially Equivalent |
| K090503 | ZQUIET MOUTHPIECE | Mar 10, 2009 | Substantially Equivalent |