The following data is part of a premarket notification filed by Electromedics, Inc. with the FDA for Autotrans Bt795.
| Device ID | K812292 |
| 510k Number | K812292 |
| Device Name: | AUTOTRANS BT795 |
| 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 | 1981-08-13 |
| Decision Date | 1981-10-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20613994744986 | K812292 | 000 |
| 00673978524870 | K812292 | 000 |
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| 10673978522217 | K812292 | 000 |