The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Ev1000 Platform Model: Ev1000a, Ev1000db, Ev1000m.
Device ID | K100709 |
510k Number | K100709 |
Device Name: | EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M |
Classification | Computer, Diagnostic, Pre-programmed, Single-function |
Applicant | EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
Contact | Patricia Milbank, Jd |
Correspondent | Patricia Milbank, Jd EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
Product Code | DXG |
CFR Regulation Number | 870.1435 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-03-12 |
Decision Date | 2010-12-07 |
Summary: | summary |