510(k) K152208
K152208 is an FDA 510(k) premarket notification submitted by Belmont Instrument Corporation for the device "The Belmont Hyperthermia Pump". The FDA issued a decision of Substantially Equivalent on September 2, 2015. The device falls under product code LGZ (Warmer, Thermal, Infusion Fluid), a Class II device regulated under 21 CFR 880.5725. Belmont Instrument Corporation has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 2, 2015
- Date Received
- August 7, 2015
- 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