510(k) K972284
K972284 is an FDA 510(k) premarket notification submitted by Belmont Instrument Corp. for the device "FLUID MANAGEMENT SYSTEM". The FDA issued a decision of ST on November 13, 1997. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Belmont Instrument Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- ST ()
- Decision Date
- November 13, 1997
- Date Received
- June 19, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Infusion
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type