FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring
K Number: K221889
·
Decision Oct 6, 2022
Classifications
1
FEI Numbers
105
Registration Numbers
105
Same Product Code
212
Applicant Total
2
Review Days
99
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Basic Information
- Device Name
- ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring
- K Number
- K221889
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 872.5570
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Prosomnus Sleep Technologies
- Date Received
- June 29, 2022
- Decision Date
- October 6, 2022
- 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 Prosomnus Sleep Technologies
| K Number | Device Name | ||
|---|---|---|---|
| K252765 | ProSomnus RPMO2 OSA Device (RPMO2 OSA) | Apr 6, 2026 | Substantially Equivalent |