The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corp. with the FDA for Cdi Blood Parameter Monitoring System 500.
| Device ID | K123039 |
| 510k Number | K123039 |
| Device Name: | CDI BLOOD PARAMETER MONITORING SYSTEM 500 |
| Classification | Monitor, Blood-gas, On-line, Cardiopulmonary Bypass |
| Applicant | TERUMO CARDIOVASCULAR SYSTEMS CORP. 6200 JACKSON RD. Ann Arbor, MI 48103 |
| Contact | Kevin Kong |
| Correspondent | Kevin Kong TERUMO CARDIOVASCULAR SYSTEMS CORP. 6200 JACKSON RD. 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 | 2012-09-28 |
| Decision Date | 2012-11-20 |
| Summary: | summary |