FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IV ADMIN. SET FOR MVP 1 INFUSION PUMP
K Number: K843311
·
Decision Mar 13, 1985
Classifications
1
FEI Numbers
149
Registration Numbers
149
Same Product Code
847
Applicant Total
16
Review Days
202
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Basic Information
- Device Name
- IV ADMIN. SET FOR MVP 1 INFUSION PUMP
- K Number
- K843311
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Ziehm International, Inc.
- Date Received
- August 23, 1984
- Decision Date
- March 13, 1985
- 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 Ziehm International, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K011292 | ZIEHM VISION | Jun 20, 2001 | Substantially Equivalent |
| K910455 | IMS DISPOSABLE HOLDER WITH NEEDLE RETRACTOR | Feb 14, 1991 | Substantially Equivalent |
| K902196 | MODIFIED STICK-GARD SAFETY NEEDLE | Jun 26, 1990 | Substantially Equivalent |
| K894021 | MOBILE X-RAY UNIT | Sep 1, 1989 | Substantially Equivalent |
| K894041 | PUMP-JECT SYRINGE WITH LUER-LOCK | Aug 28, 1989 | Substantially Equivalent |
| K890620 | STICK-GARD SAFETY NEEDLE | Feb 28, 1989 | Substantially Equivalent |
| K882133 | MAMMO M | Sep 19, 1988 | Substantially Equivalent |
| K842263 | MTP E.V. INFUSION PUMP | Jul 25, 1984 | Substantially Equivalent |
| K831407 | CARDIAC OUTPUT COMPUTER | Oct 14, 1983 | Substantially Equivalent |
| K830453 | IV ADMINISTRATION SETS - MVP INFUSION | Apr 30, 1983 | Substantially Equivalent |