The following data is part of a premarket notification filed by Level 1 Technologies, Inc. with the FDA for Blood And Plasma Warming Devices.
| Device ID | BK860023 |
| 510k Number | BK860023 |
| Device Name: | Blood And Plasma Warming Devices |
| Classification | Device, Warming. Blood And Plasma |
| Applicant | Level 1 Technologies, Inc. 160 Weymouth Street Rockland, MA 02370 |
| 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 | 1986-05-08 |
| Decision Date | 1986-09-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00695085800210 | BK860023 | 000 |
| 10695085406006 | BK860023 | 000 |
| 20695085406010 | BK860023 | 000 |
| 50695085410018 | BK860023 | 000 |
| 10695085430001 | BK860023 | 000 |
| 50695085430016 | BK860023 | 000 |
| 20695085403101 | BK860023 | 000 |
| 10695085403609 | BK860023 | 000 |
| 10695085433002 | BK860023 | 000 |
| 30695085400305 | BK860023 | 000 |
| 10695085410003 | BK860023 | 000 |
| 10695085403005 | BK860023 | 000 |
| 35019315057919 | BK860023 | 000 |
| 30695085400107 | BK860023 | 000 |