FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SKILCRAFT - TRACHEOTOMY CARE KIT 3 COMPARTMENT
K Number: K844051
·
Decision Jan 18, 1985
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
0
Applicant Total
3
Review Days
93
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Basic Information
- Device Name
- SKILCRAFT - TRACHEOTOMY CARE KIT 3 COMPARTMENT
- K Number
- K844051
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5800
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Washington-Greene County Branch Pennsylvania Assoc
- Date Received
- October 17, 1984
- Decision Date
- January 18, 1985
- Product Code
- NXA
- 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 |
|---|---|---|---|
| NXA | Tracheotomy Care Kit | FDA class 2 | Anesthesiology |