FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PILOT TUBE REPAIR KIT
K Number: K113644
·
Decision Jan 26, 2012
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
38
Applicant Total
45
Review Days
45
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Basic Information
- Device Name
- PILOT TUBE REPAIR KIT
- K Number
- K113644
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.5750
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Instrumentation Industries, Inc.
- Date Received
- December 12, 2011
- Decision Date
- January 26, 2012
- Product Code
- BSK
- 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 |
|---|---|---|---|
| BSK | Cuff, Tracheal Tube, Inflatable | FDA class 2 | Anesthesiology |
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Cuffix
FDA 510(k)
FDA Class 2
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