Belmont Hyperthermia Pump
FDA 510(k) K131519 · Belmont Instrument Corp.
510(k) numberK131519
Submission
- Device name
- Belmont Hyperthermia Pump
- Applicant
- Belmont Instrument Corp.
Billerica, MA, US - Received
- May 28, 2013
- Decision date
- November 6, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LGZ – Warmer, Thermal, Infusion Fluid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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More from Mac Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K152208 | The Belmont Hyperthermia PumpLGZ · Special | 09/02/2015SE |
| K141654 | The Belmont Rapid InfuserFRN · Special | 07/18/2014SE |
| K112639 | The Belmont Buddy Lite Fluid WarmerBSB · Special | 11/16/2011SE |
| K091855 | The Belmont Fluid Management System/ the Belmont Rapid Infuser, Model FMS2000FRN · Special | 07/01/2009SE |
| K090508 | The Belmont Buddy Lite Fluid WarmerBSB · Special | 03/26/2009SE |
| K090089 | Belmont Hyperthermia PumpLGZ · Special | 02/12/2009SE |
| K070654 | Hyperthermia PumpLGZ · Traditional | 06/08/2007SE |
| K062774 | Belmont Buddy Plus Fluid WarmerBSB · Special | 10/19/2006SE |
| K052547 | Belmont Buddy Fluid WarmerBSB · Special | 10/13/2005SE |
| K032778 | Large Volume Fluid ReservoirLGZ · Special | 09/22/2003SE |
Questions and answers
When was Belmont Hyperthermia Pump cleared by the FDA?
Belmont Hyperthermia Pump (K131519) received a 510(k) decision of Substantially Equivalent on November 6, 2013, 162 days after the submission was received.
What is the product code of K131519?
The FDA product code is LGZ – Warmer, Thermal, Infusion Fluid, a Class II (moderate risk) device regulated under 21 CFR 880.5725.