The following data is part of a premarket notification filed by Electromedics, Inc. with the FDA for Bt-795/p Automated Autotrans.
| Device ID | K860306 |
| 510k Number | K860306 |
| Device Name: | BT-795/P AUTOMATED AUTOTRANS |
| Classification | Apparatus, Autotransfusion |
| Applicant | ELECTROMEDICS, INC. P.O. BOX 3315 Englewood, CO 80155 |
| Contact | Gary D Reeder |
| Correspondent | Gary D Reeder ELECTROMEDICS, INC. P.O. BOX 3315 Englewood, CO 80155 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-28 |
| Decision Date | 1986-03-06 |