FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HOSPIRA ENTERAL FEEDING SET, MODEL 20640
K Number: K061432
·
Decision Sep 11, 2006
Classifications
1
FEI Numbers
228
Registration Numbers
229
Same Product Code
648
Applicant Total
45
Review Days
110
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Basic Information
- Device Name
- HOSPIRA ENTERAL FEEDING SET, MODEL 20640
- K Number
- K061432
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hospira, Inc.
- Date Received
- May 24, 2006
- Decision Date
- September 11, 2006
- Product Code
- KNT
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Hospira, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K161469 | Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module | Mar 28, 2017 | Substantially Equivalent |
| K161036 | Hospira Extension Set, Hospira Primary Set | Jan 6, 2017 | Substantially Equivalent |
| K160492 | Hospira Sapphire Sets | Dec 6, 2016 | Substantially Equivalent |
| K160870 | Hospira Administration Sets | Jun 1, 2016 | Substantially Equivalent |
| K143612 | LifeCare PCA Infusion System | Apr 8, 2016 | Substantially Equivalent |
| K143087 | Hospira Blood Set | Mar 4, 2015 | Substantially Equivalent |
| K143015 | Hospira Primary Sets | Feb 25, 2015 | Substantially Equivalent |
| K141789 | PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE | Jan 16, 2015 | Substantially Equivalent |
| K142622 | IV Administration | Jan 15, 2015 | Substantially Equivalent |
| K142974 | Extension Sets | Jan 9, 2015 | Substantially Equivalent |