FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LINDE INTEGRATED VALVE (LIV)
K Number: K063354
·
Decision Apr 17, 2007
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
12
Applicant Total
2
Review Days
162
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Basic Information
- Device Name
- LINDE INTEGRATED VALVE (LIV)
- K Number
- K063354
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.2700
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Linde Gas Therapeutics
- Date Received
- November 6, 2006
- Decision Date
- April 17, 2007
- Product Code
- ECX
- 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 |
|---|---|---|---|
| ECX | Cylinder, Compressed Gas, And Valve | FDA class 1 | Anesthesiology |
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Other Clearances by Linde Gas Therapeutics
| K Number | Device Name | ||
|---|---|---|---|
| K072926 | HELONTIX VENT | Oct 15, 2008 | Substantially Equivalent |