510(k) K880006
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 24, 1988
- Date Received
- January 4, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Controller, Infusion, Intravascular, Electronic
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type