The following data is part of a premarket notification filed by Icu Medical Inc. with the FDA for Cogent Hemodynamic Monitoring System.
| Device ID | K152006 |
| 510k Number | K152006 |
| Device Name: | Cogent Hemodynamic Monitoring System |
| Classification | Blood Pressure Cuff |
| Applicant | ICU MEDICAL INC. 951 CALLE AMANECER San Clemente, CA 92673 |
| Contact | Natalie Hepworth |
| Correspondent | Natalie Hepworth ICU MEDICAL INC. 951 CALLE AMANECER San Clemente, CA 92673 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-21 |
| Decision Date | 2016-05-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840619085636 | K152006 | 000 |
| 00840619085421 | K152006 | 000 |
| 00887709094314 | K152006 | 000 |
| 00840619099459 | K152006 | 000 |
| 00840619047078 | K152006 | 000 |