The following data is part of a premarket notification filed by Electromedics, Inc. with the FDA for Arterial Blood Filter Electro. Air* Star 40 And 20.
| Device ID | K902723 |
| 510k Number | K902723 |
| Device Name: | ARTERIAL BLOOD FILTER ELECTRO. AIR* STAR 40 AND 20 |
| Classification | Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| 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 | DTM |
| CFR Regulation Number | 870.4260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-19 |
| Decision Date | 1990-12-13 |