The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corporation with the FDA for Cdi Blood Parameter Monitoring System 550.
| Device ID | K182110 |
| 510k Number | K182110 |
| Device Name: | CDI Blood Parameter Monitoring System 550 |
| Classification | Monitor, Blood-gas, On-line, Cardiopulmonary Bypass |
| Applicant | Terumo Cardiovascular Systems Corporation 6200 Jackson Road Ann Arbor, MI 48103 |
| Contact | Bryan K. Hann |
| Correspondent | Bryan K. Hann Terumo Cardiovascular Systems Corporation 6200 Jackson Road Ann Arbor, MI 48103 |
| Product Code | DRY |
| CFR Regulation Number | 870.4330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-06 |
| Decision Date | 2018-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00886799001790 | K182110 | 000 |
| 00886799001783 | K182110 | 000 |