FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
Retrograde Intubation Set
K Number: DEN170055
·
Decision Dec 12, 2018
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
0
Applicant Total
175
Review Days
443
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Basic Information
- Device Name
- Retrograde Intubation Set
- K Number
- DEN170055
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 868.5095
- Medical Specialty
- Anesthesiology
- Decision
- Unknown
- Applicant
- Cook Incorporated
- Date Received
- September 25, 2017
- Decision Date
- December 12, 2018
- Product Code
- QCX
- 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 |
|---|---|---|---|
| QCX | Retrograde Intubation Set | FDA class 2 | Anesthesiology |
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