FDA 510(k) Premarket Notification K070320: EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01

Submission Details & Decision

Normalized public record details for 510(k) notification K070320.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K070320

Applicant / Sponsor

Edwards Lifesciences Services GmbH

Device Name

EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01

Product Code

KDI

Decision Date

2007-06-07

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Gastroenterology, Urology (GU)

Clearance Type

Traditional

Third Party Flag

Date Received

2007-02-02

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