FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
O2Vent Optima
K Number: K190236
·
Decision Aug 29, 2019
Classifications
1
FEI Numbers
105
Registration Numbers
105
Same Product Code
212
Applicant Total
4
Review Days
204
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- O2Vent Optima
- K Number
- K190236
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5570
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Oventus Manufacturing Pty, Ltd.
- Date Received
- February 6, 2019
- Decision Date
- August 29, 2019
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LRK), ordered by most recent decision date.
Virtus
FDA 510(k)
FDA Class 2
·Dental
Snorbliss® Anti-Snoring Device
FDA 510(k)
FDA Class 2
·Dental
Dormiva Anti-Snoring Mouth Guard
FDA 510(k)
FDA Class 2
·Dental
ShaeferH
FDA 510(k)
FDA Class 2
·Dental
Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)
FDA 510(k)
FDA Class 2
·Dental
Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)
FDA 510(k)
FDA Class 2
·Dental