FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML
K Number: K001287
·
Decision Jun 9, 2000
Classifications
1
FEI Numbers
86
Registration Numbers
86
Same Product Code
116
Applicant Total
6
Review Days
46
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Basic Information
- Device Name
- EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML
- K Number
- K001287
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5025
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sorenson Medical, Inc.
- Date Received
- April 24, 2000
- Decision Date
- June 9, 2000
- Product Code
- KPE
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| KPE | Container, I.V. | FDA class 2 | General Hospital |
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Other Clearances by Sorenson Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K052221 | AMBIT PUSH & PLAY AMBULATORY INFUSION PUMP | Dec 8, 2005 | Substantially Equivalent |
| K033325 | AMBIT CONTINUOUS AMBULATORY INFUSION PUMP | Nov 6, 2003 | Substantially Equivalent |
| K033425 | AMBIT INTERMITTENT AMBULATORY INFUSION PUMP | Nov 6, 2003 | Substantially Equivalent |
| K002434 | PALM PUMP | Aug 23, 2000 | Substantially Equivalent |
| K991363 | 30 PUMP, CONTINUOUS LOW FLOW, 200 PUMP, INTERMITTENT WITH KVO OR CONTINUOUS, PCA PUMP, PAIN MANAGEMENT, PCEA PUMP, EPIDU | May 13, 1999 | Substantially Equivalent |