FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DreamWear Silicone Pillows Mask
K Number: K210844
·
Decision Aug 24, 2021
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
459
Applicant Total
172
Review Days
155
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Basic Information
- Device Name
- DreamWear Silicone Pillows Mask
- K Number
- K210844
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5905
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Respironics, Inc.
- Date Received
- March 22, 2021
- Decision Date
- August 24, 2021
- 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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| K Number | Device Name | ||
|---|---|---|---|
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| K202142 | Sleepware G3 | Oct 29, 2020 | Substantially Equivalent |
| K201439 | Ventilator, Non-continuous (Respirator) | Sep 25, 2020 | Substantially Equivalent |
| K200480 | DreamStation 2 System, DreamStation 2 Advanced System | Jul 10, 2020 | Substantially Equivalent |
| K183226 | Care Orchestrator Essence | Oct 18, 2019 | Substantially Equivalent |
| K183625 | SomnaPatch | Oct 18, 2019 | Substantially Equivalent |
| K181166 | Trilogy Evo | Jul 18, 2019 | Substantially Equivalent |
| K181170 | Trilogy Evo Universal | Jul 18, 2019 | Substantially Equivalent |