FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
Curve Positive Airway Pressure System
K Number: DEN170089
·
Decision Jun 5, 2018
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
1
Applicant Total
1
Review Days
173
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Basic Information
- Device Name
- Curve Positive Airway Pressure System
- K Number
- DEN170089
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 868.5273
- Medical Specialty
- Anesthesiology
- Decision
- Unknown
- Applicant
- Fresca Medical
- Date Received
- December 14, 2017
- Decision Date
- June 5, 2018
- Product Code
- QBY
- 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 |
|---|---|---|---|
| QBY | Positive Airway Pressure System | FDA class 2 | Anesthesiology |
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