FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GAS SAMPLING LINES
K Number: K023579
·
Decision Jan 28, 2003
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
304
Applicant Total
16
Review Days
96
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Basic Information
- Device Name
- GAS SAMPLING LINES
- K Number
- K023579
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1400
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Promedic, Inc.
- Date Received
- October 24, 2002
- Decision Date
- January 28, 2003
- Product Code
- CCK
- 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 |
|---|---|---|---|
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | FDA class 2 | Anesthesiology |
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|---|---|---|---|
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| K060497 | BABYAIR | Jul 11, 2006 | Substantially Equivalent |
| K060842 | REVJET TURBO | Jun 21, 2006 | Substantially Equivalent |
| K052903 | PEDIATRIC FEEDING TUBE | Nov 9, 2005 | Substantially Equivalent |
| K031409 | URINARY CATHETERS | Jun 17, 2003 | Substantially Equivalent |
| K024190 | FENESTRATED INFUSION CATHETER | Mar 17, 2003 | Substantially Equivalent |
| K020005 | INFANT FEEDING TUBES | Jul 16, 2002 | Substantially Equivalent |
| K970102 | FILTER | Jun 24, 1997 | Substantially Equivalent |