The following data is part of a premarket notification filed by Boehringer Laboratories with the FDA for Autovac(r) Autotransfusion System, 7900 Series.
| Device ID | K901138 |
| 510k Number | K901138 |
| Device Name: | AUTOVAC(R) AUTOTRANSFUSION SYSTEM, 7900 SERIES |
| Classification | Apparatus, Autotransfusion |
| Applicant | BOEHRINGER LABORATORIES P.O. BOX 870 Norristown, PA 19404 |
| Contact | Karpowicz, M.e. |
| Correspondent | Karpowicz, M.e. BOEHRINGER LABORATORIES P.O. BOX 870 Norristown, PA 19404 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-12 |
| Decision Date | 1990-06-18 |