The following data is part of a premarket notification filed by Edwards Lifesciences, Llc with the FDA for Hemosphere Advanced Monitor, Hemosphere Tissue Oximetry Module.
| Device ID | K190205 |
| 510k Number | K190205 |
| Device Name: | HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module |
| 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 | 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 | 2019-02-04 |
| Decision Date | 2019-08-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103200355 | K190205 | 000 |