510(k) K032778
K032778 is an FDA 510(k) premarket notification submitted by Belmont Instrument Corp. for the device "LARGE VOLUME FLUID RESERVOIR". The FDA issued a decision of Substantially Equivalent on September 22, 2003. The device falls under product code LGZ (Warmer, Thermal, Infusion Fluid), 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
- SESE (Substantially Equivalent)
- Decision Date
- September 22, 2003
- Date Received
- September 8, 2003
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Warmer, Thermal, Infusion Fluid
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type