FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SNOREX
K Number: K971818
·
Decision Dec 18, 1997
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
26
Applicant Total
1
Review Days
216
Basic Information
- Device Name
- SNOREX
- K Number
- K971818
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5570
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SNOREX (NZ) LTD.
- Date Received
- May 16, 1997
- Decision Date
- December 18, 1997
- Product Code
- LQZ
- 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 |
|---|---|---|---|
| LQZ | Device, Jaw Repositioning | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LQZ), ordered by most recent decision date.
AIO Breathe
FDA 510(k)
FDA Class 2
·Dental
RADx Intraoral Appliance for Snoring and Sleep Apnea
FDA 510(k)
FDA Class 2
·Dental
The Slide
FDA 510(k)
FDA Class 2
·Dental
Slow Wave DS8
FDA 510(k)
FDA Class 2
·Dental
The NightBlocks Appliance
FDA 510(k)
FDA Class 2
·Dental
SML-OSA2 Appliances
FDA 510(k)
FDA Class 2
·Dental