The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Arterial Pressure Monitoring Set/tray.
| Device ID | K180792 |
| 510k Number | K180792 |
| Device Name: | Arterial Pressure Monitoring Set/Tray |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Contact | Johnathan Liu |
| Correspondent | Johnathan Liu Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-27 |
| Decision Date | 2018-11-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002583993 | K180792 | 000 |
| 00827002583986 | K180792 | 000 |