The following data is part of a premarket notification filed by Augustine Medical, Inc. with the FDA for Blood And Plasma Warming Devices.
| Device ID | BK940032 |
| 510k Number | BK940032 |
| Device Name: | Blood And Plasma Warming Devices |
| Classification | Device, Warming. Blood And Plasma |
| Applicant | Augustine Medical, Inc. 10393 West 70 Th Street Eden Prairie, MN 55344 |
| Product Code | KZL |
| CFR Regulation Number | 864.9205 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-01 |
| Decision Date | 1994-09-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50707387781922 | BK940032 | 0 |
| 50608223241108 | BK940032 | 0 |
| 30608223900261 | BK940032 | 0 |
| 30608223241104 | BK940032 | 0 |