The following data is part of a premarket notification filed by Edwards Lifesiences, Llc with the FDA for Hemosphere Advanced Monitoring Platform, Hemosphere Clearsight Module.
| Device ID | K201446 |
| 510k Number | K201446 |
| Device Name: | HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | Edwards Lifesiences, LLC One Edwards Way Irvine, CA 92614 |
| Contact | Varad Raghuwanshi |
| Correspondent | Varad Raghuwanshi Edwards Lifesiences, LLC One Edwards Way Irvine, CA 92614 |
| Product Code | DQK |
| Subsequent Product Code | DQE |
| Subsequent Product Code | DSB |
| Subsequent Product Code | DXN |
| Subsequent Product Code | MUD |
| Subsequent Product Code | QAQ |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-01 |
| Decision Date | 2020-10-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103202762 | K201446 | 000 |