The following data is part of a premarket notification filed by Edwards Lifesciences, Llc with the FDA for Hemosphere Advanced Monitor, Hemosphere Pressure Cable.
| Device ID | K180881 |
| 510k Number | K180881 |
| Device Name: | HemoSphere Advanced Monitor, HemoSphere Pressure Cable |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | Edwards Lifesciences, LLC One Edwards Way Irvine, CA 92614 |
| Contact | Chirag Shah |
| Correspondent | Chirag Shah Edwards Lifesciences, LLC One Edwards Way Irvine, CA 92614 |
| Product Code | DQK |
| Subsequent Product Code | DQE |
| Subsequent Product Code | QAQ |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-04 |
| Decision Date | 2018-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103199321 | K180881 | 000 |
| 00690103199338 | K180881 | 000 |