The following data is part of a premarket notification filed by Belmont Instrument Corporation with the FDA for Blood And Plasma Warming Devices.
| Device ID | BK150301 |
| 510k Number | BK150301 |
| Device Name: | Blood And Plasma Warming Devices |
| Classification | Device, Warming. Blood And Plasma |
| Applicant | Belmont Instrument Corporation 780 Boston Road Billerica, MA 01821 US |
| Product Code | KZL |
| CFR Regulation Number | 864.9205 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-11 |
| Decision Date | 2015-09-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20896128002828 | BK150301 | 0 |
| 10896128002821 | BK150301 | 0 |
| 00896128002855 | BK150301 | 0 |
| 00896128002848 | BK150301 | 0 |
| 00896128002831 | BK150301 | 0 |
| 00896128002824 | BK150301 | 0 |