The following data is part of a premarket notification filed by Belmont Instrument Corporation with the FDA for The Belmont Hyperthermia Pump.
| Device ID | K152208 |
| 510k Number | K152208 |
| Device Name: | The Belmont Hyperthermia Pump |
| Classification | Warmer, Thermal, Infusion Fluid |
| Applicant | BELMONT INSTRUMENT CORPORATION 780 BOSTON ROAD Billerica, MA 01821 |
| Contact | Uraiwan P Labadini |
| Correspondent | Uraiwan P Labadini BELMONT INSTRUMENT CORPORATION 780 BOSTON ROAD 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 | 2015-08-07 |
| Decision Date | 2015-09-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 80896128002134 | K152208 | 000 |
| 00896128002572 | K152208 | 000 |
| 00896128002213 | K152208 | 000 |
| 00896128002480 | K152208 | 000 |
| 00896128002473 | K152208 | 000 |
| 00896128002466 | K152208 | 000 |
| 00896128002299 | K152208 | 000 |
| 00896128002282 | K152208 | 000 |
| 00896128002275 | K152208 | 000 |
| 00896128002268 | K152208 | 000 |
| 00896128002251 | K152208 | 000 |
| 00896128002244 | K152208 | 000 |
| 00896128002237 | K152208 | 000 |
| 00896128002190 | K152208 | 000 |
| 00896128002176 | K152208 | 000 |
| 00896128002169 | K152208 | 000 |
| 00896128002145 | K152208 | 000 |
| 00896128002152 | K152208 | 000 |
| 00896128002183 | K152208 | 000 |
| 70896128002137 | K152208 | 000 |
| 60896128002130 | K152208 | 000 |
| 50896128002133 | K152208 | 000 |
| 40896128002136 | K152208 | 000 |
| 30896128002139 | K152208 | 000 |
| 20896128002132 | K152208 | 000 |
| 10896128002579 | K152208 | 000 |
| 10896128002456 | K152208 | 000 |
| 10896128002296 | K152208 | 000 |
| 10896128002289 | K152208 | 000 |
| 10896128002265 | K152208 | 000 |
| 10896128002135 | K152208 | 000 |
| 00896128002206 | K152208 | 000 |
| 00896128002589 | K152208 | 000 |
| 00896128002220 | K152208 | 000 |
| 00896128002077 | K152208 | 000 |