FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MX820-5 PRESSURE INFUSOR 500CC MX820-10
K Number: K800560
·
Decision Apr 29, 1980
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
34
Applicant Total
48
Review Days
48
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Basic Information
- Device Name
- MX820-5 PRESSURE INFUSOR 500CC MX820-10
- K Number
- K800560
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5420
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Medex, Inc.
- Date Received
- March 12, 1980
- Decision Date
- April 29, 1980
- Product Code
- KZD
- 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 |
|---|---|---|---|
| KZD | Infusor, Pressure, For I.V. Bags | FDA class 1 | General Hospital |
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KAWASUMI LABORATORIES K-CUFF
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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 |
| K000328 | MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP | May 9, 2000 | 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 |