The following data is part of a premarket notification filed by Belmont Instrument Corp. with the FDA for Belmont Hyperthermia Pump.
| Device ID | K090089 |
| 510k Number | K090089 |
| Device Name: | BELMONT HYPERTHERMIA PUMP |
| Classification | Warmer, Thermal, Infusion Fluid |
| Applicant | BELMONT INSTRUMENT CORP. 780 BOSTON RD. Billerica, MA 01821 |
| Contact | Uraiwan Labadini |
| Correspondent | Uraiwan Labadini BELMONT INSTRUMENT CORP. 780 BOSTON RD. Billerica, MA 01821 |
| Product Code | LGZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-14 |
| Decision Date | 2009-02-12 |