The following data is part of a premarket notification filed by Level 1 Technologies, Inc. with the FDA for Level 1 Blood Stream Recovery System.
| Device ID | K942844 |
| 510k Number | K942844 |
| Device Name: | LEVEL 1 BLOOD STREAM RECOVERY SYSTEM |
| Classification | Apparatus, Autotransfusion |
| Applicant | LEVEL 1 TECHNOLOGIES, INC. 160 WEYMOUTH ST. Rockland, MA 02370 |
| Contact | Wesley H Verkaart |
| Correspondent | Wesley H Verkaart LEVEL 1 TECHNOLOGIES, INC. 160 WEYMOUTH ST. Rockland, MA 02370 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-16 |
| Decision Date | 1996-04-26 |
| Summary: | summary |