FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DeltaWave Nasal Pillow System
K Number: K253939
·
Decision Jan 7, 2026
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
459
Applicant Total
1
Review Days
29
Basic Information
- Device Name
- DeltaWave Nasal Pillow System
- K Number
- K253939
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.5905
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- RemSleep Holdings, Inc.
- Date Received
- December 9, 2025
- Decision Date
- January 7, 2026
- Product Code
- BZD
- Advisory Committee
- Anesthesiology
- 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 |
|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | FDA class 2 | Anesthesiology |
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