The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Scimed Ultrox True Membrane Oxygen Syst, Ultrox Ii.
| Device ID | K894103 |
| 510k Number | K894103 |
| Device Name: | SCIMED ULTROX TRUE MEMBRANE OXYGEN SYST, ULTROX II |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | SCIMED LIFE SYSTEMS, INC. 2905 NORTHWEST BLVD. SUITE 60 Plymouth, MN 55441 |
| Contact | Swanson Lano |
| Correspondent | Swanson Lano SCIMED LIFE SYSTEMS, INC. 2905 NORTHWEST BLVD. SUITE 60 Plymouth, MN 55441 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-09 |
| Decision Date | 1989-09-21 |