510(k) K844556
K844556 is an FDA 510(k) premarket notification submitted by The Timeter Group for the device "KHM 2000 DRIP WATCHER". The FDA issued a decision of Substantially Equivalent on January 14, 1985. The device falls under product code FLN (Monitor, Electric For Gravity Flow Infusion Systems), a Class II device regulated under 21 CFR 880.2420. The Timeter Group has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 14, 1985
- Date Received
- November 21, 1984
- 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