FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP
K Number: K000328
·
Decision May 9, 2000
Classifications
1
FEI Numbers
149
Registration Numbers
149
Same Product Code
847
Applicant Total
48
Review Days
97
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Basic Information
- Device Name
- MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP
- K Number
- K000328
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medex, Inc.
- Date Received
- February 2, 2000
- Decision Date
- May 9, 2000
- Product Code
- FRN
- 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 |
|---|---|---|---|
| FRN | Pump, Infusion | FDA class 2 | General Hospital |
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Other Clearances by Medex, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K042432 | PHARMGUARD TOOLBOX, MODEL G6000782 | Jan 4, 2005 | Substantially Equivalent |
| K040899 | MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP | Apr 30, 2004 | Substantially Equivalent |
| K020780 | TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP | May 20, 2002 | Substantially Equivalent |
| K982640 | MEDEX 3000 SERIES SYRINGE INFUSION PUMP | Apr 6, 1999 | Substantially Equivalent - Subject to Tracking Reg. |
| K982123 | CONTRAST CONTROL DEVICE | Jul 21, 1998 | Substantially Equivalent |
| K955231 | MEDFUSION MODEL 2001 SYRINGE INFUSION PUMP | Jul 18, 1996 | Substantially Equivalent - Subject to Tracking Reg. |
| K961404 | MX960 REUSABLE PRESSURE TRANSDUCER | Jun 27, 1996 | Substantially Equivalent |
| K961527 | MX703 AND MX730 CONTINUOUS FLUSH DEVICES | Jun 6, 1996 | Substantially Equivalent |
| K954970 | STOPCOCK & LUER LOCK PLUG | Apr 22, 1996 | Substantially Equivalent |
| K952160 | INTRAVASCULAR (I-V) ADMININISTRATION SET (DVGENPERS FPA) | Sep 21, 1995 | Substantially Equivalent |