The following data is part of a premarket notification filed by Edwards Lifesciences, Llc with the FDA for Ev1000 Clinical Platform Non-invasive (ni) With Clearsight Finger Cuffs Or Clearsight System.
Device ID | K182245 |
510k Number | K182245 |
Device Name: | EV1000 Clinical Platform Non-Invasive (NI) With ClearSight Finger Cuffs Or ClearSight System |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | Edwards Lifesciences, LLC One Edwards Way Irvine, CA 92614 |
Contact | Christine Chun |
Correspondent | Christine Chun Edwards Lifesciences, LLC One Edwards Way Irvine, CA 92614 |
Product Code | DXN |
Subsequent Product Code | DSB |
Subsequent Product Code | DXG |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-08-20 |
Decision Date | 2018-11-30 |
Summary: | summary |