The following data is part of a premarket notification filed by Edwards Lifesciences, Llc with the FDA for Flo Trac Sensor, Volume View Sensor.
| Device ID | K152980 |
| 510k Number | K152980 |
| Device Name: | Flo Trac Sensor, Volume View Sensor |
| Classification | Transducer, Blood-pressure, Extravascular |
| Applicant | Edwards Lifesciences, LLC One Edwards Way Irvine, CA 92614 |
| Contact | Andrew S Mazurkiewicz |
| Correspondent | Andrew S Mazurkiewicz Edwards Lifesciences, LLC One Edwards Way Irvine, CA 92614 |
| Product Code | DRS |
| CFR Regulation Number | 870.2850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-09 |
| Decision Date | 2016-01-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50690103201173 | K152980 | 000 |
| 00690103201130 | K152980 | 000 |
| 00690103197761 | K152980 | 000 |
| 50690103197773 | K152980 | 000 |
| 00690103197792 | K152980 | 000 |
| 00690103197808 | K152980 | 000 |
| 50690103197827 | K152980 | 000 |
| 50690103198077 | K152980 | 000 |
| 50690103200947 | K152980 | 000 |
| 00690103201086 | K152980 | 000 |
| 00690103201161 | K152980 | 000 |
| 50690103201067 | K152980 | 000 |