FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
The iNAP One Sleep Therapy System
K Number: K220907
·
Decision Jun 16, 2023
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
5
Applicant Total
2
Review Days
444
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Basic Information
- Device Name
- The iNAP One Sleep Therapy System
- K Number
- K220907
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5570
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Somnics, Inc.
- Date Received
- March 29, 2022
- Decision Date
- June 16, 2023
- Product Code
- OZR
- Advisory Committee
- Dental
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| OZR | Intraoral Pressure Gradient Device | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OZR), ordered by most recent decision date.
The iNAP One Sleep Therapy System
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ATTUNE SLEEP APNEA SYSTEM
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Other Clearances by Somnics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K152660 | HYPNOSPAD | Nov 9, 2016 | Substantially Equivalent |