510(k) K882167
- Device
- Ivy Commander, Model 600
- Applicant
- IVY MEDICAL, INC.
- 510(k) number
- K882167
- Product code
- LDR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-09-23
- Date received
- 1988-05-24
- Regulation
- 880.5725
- Classification name
- Controller, Infusion, Intravascular, Electronic
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- STEPHEN A LEVIE
- Address
- 7411 Washington Ave. S. Minneapolis MN US 55435 55435
FDA Registration Numbers
- 1223925
- 1018470
- 1320894
- 1220973
- 1287243
- 3007305485
Source Documents
510(k) summary PDF not indicated by FDA
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