510(k) K973025
K973025 is an FDA 510(k) premarket notification submitted by Northgate Technologies, Inc. for the device "FLUID CENTURION (4-100-00)". The FDA issued a decision of Substantially Equivalent on November 20, 1997. The device falls under product code FLN (Monitor, Electric For Gravity Flow Infusion Systems), a Class II device regulated under 21 CFR 880.2420. Northgate Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 20, 1997
- Date Received
- August 14, 1997
- 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