The following data is part of a premarket notification filed by Edwards Lfesciences with the FDA for Hemosphere Advanced Monitor, Viewfinder Remote, Hemosphere Advanced Monitoring Platform.
| Device ID | K211465 |
| 510k Number | K211465 |
| Device Name: | HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | Edwards Lfesciences One Edwards Way Irvine, CA 92614 |
| Contact | Chirag Shah |
| Correspondent | Chirag Shah Edwards Lfesciences 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 | 2021-05-11 |
| Decision Date | 2021-07-08 |