The following data is part of a premarket notification filed by 3m Company with the FDA for Cdi(tm) H/s Cuvette, Modification.
| Device ID | K915265 |
| 510k Number | K915265 |
| Device Name: | CDI(TM) H/S CUVETTE, MODIFICATION |
| Classification | Monitor, Blood-gas, On-line, Cardiopulmonary Bypass |
| Applicant | 3M COMPANY 1311 VALENCIA AVE. Tustin, CA 92680 |
| Contact | Ann-marie Butler |
| Correspondent | Ann-marie Butler 3M COMPANY 1311 VALENCIA AVE. Tustin, CA 92680 |
| Product Code | DRY |
| CFR Regulation Number | 870.4330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-19 |
| Decision Date | 1992-01-15 |