The following data is part of a premarket notification filed by Electromedics, Inc. with the FDA for Bt 795/a Autotrans.
| Device ID | K830735 |
| 510k Number | K830735 |
| Device Name: | BT 795/A AUTOTRANS |
| Classification | Apparatus, Autotransfusion |
| Applicant | ELECTROMEDICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-08 |
| Decision Date | 1983-05-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169108363 | K830735 | 000 |
| 00643169108356 | K830735 | 000 |
| 00643169108349 | K830735 | 000 |
| 00643169108332 | K830735 | 000 |
| 00643169108325 | K830735 | 000 |
| 00681490472692 | K830735 | 000 |
| 00681490472685 | K830735 | 000 |