The following data is part of a premarket notification filed by Electromedics, Inc. with the FDA for Electromedics Bt422-120 And Bt422-40.
| Device ID | K903392 |
| 510k Number | K903392 |
| Device Name: | ELECTROMEDICS BT422-120 AND BT422-40 |
| Classification | Apparatus, Autotransfusion |
| Applicant | ELECTROMEDICS, INC. P.O. BOX 3315 Englewood, CO 80155 |
| Contact | Harold W Bryan |
| Correspondent | Harold W Bryan 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 | 1990-07-27 |
| Decision Date | 1990-09-06 |