The following data is part of a premarket notification filed by Polystan C/o Vitalcor, Inc. with the FDA for Po 2 Lytrode.
| Device ID | K843538 |
| 510k Number | K843538 |
| Device Name: | PO 2 LYTRODE |
| Classification | Monitor, Blood-gas, On-line, Cardiopulmonary Bypass |
| Applicant | POLYSTAN C/O VITALCOR, INC. WALGERHOLM 8 Ballerup Denmark , |
| Contact | Henning S Larsen |
| Correspondent | Henning S Larsen POLYSTAN C/O VITALCOR, INC. WALGERHOLM 8 Ballerup Denmark , |
| Product Code | DRY |
| CFR Regulation Number | 870.4330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-07 |
| Decision Date | 1984-10-18 |