510(k) K030136
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 7, 2003
- Date Received
- January 14, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Electric For Gravity Flow Infusion Systems
- Device Class
- Class II
- Regulation Number
- 880.2420
- Review Panel
- HO
- Submission Type