The following data is part of a premarket notification filed by Belmont Instrument Corporation with the FDA for The Belmont Rapid Infuser.
| Device ID | K141654 |
| 510k Number | K141654 |
| Device Name: | THE BELMONT RAPID INFUSER |
| Classification | Pump, Infusion |
| 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 | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-20 |
| Decision Date | 2014-07-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 80896128002776 | K141654 | 000 |
| 10896128002050 | K141654 | 000 |
| 10896128002029 | K141654 | 000 |
| 10896128002005 | K141654 | 000 |
| 00896128002534 | K141654 | 000 |
| 00896128002084 | K141654 | 000 |
| 00896128002060 | K141654 | 000 |
| 00896128002022 | K141654 | 000 |
| 00896128002008 | K141654 | 000 |
| 00896128002053 | K141654 | 000 |
| 00896128002909 | K141654 | 000 |
| 00896128002893 | K141654 | 000 |
| 00896128002886 | K141654 | 000 |
| 00896128002879 | K141654 | 000 |
| 00896128002817 | K141654 | 000 |
| 00896128002800 | K141654 | 000 |
| 00896128002794 | K141654 | 000 |
| 10896128002067 | K141654 | 000 |
| 10896128002081 | K141654 | 000 |
| 10896128002630 | K141654 | 000 |
| 80896128002752 | K141654 | 000 |
| 70896128002779 | K141654 | 000 |
| 70896128002755 | K141654 | 000 |
| 60896128002772 | K141654 | 000 |
| 60896128002758 | K141654 | 000 |
| 50896128002775 | K141654 | 000 |
| 50896128002751 | K141654 | 000 |
| 40896128002778 | K141654 | 000 |
| 40896128002754 | K141654 | 000 |
| 30896128002771 | K141654 | 000 |
| 30896128002757 | K141654 | 000 |
| 20896128002774 | K141654 | 000 |
| 20896128002750 | K141654 | 000 |
| 10896128002777 | K141654 | 000 |
| 10896128002760 | K141654 | 000 |
| 10896128002753 | K141654 | 000 |
| 00896128002787 | K141654 | 000 |