Electrofluidgraph

FDA 510(k) K091369 · Akern USA, LLC

Substantially Equivalent

510(k) numberK091369

Submission

Device name
Electrofluidgraph
Applicant
Akern USA, LLC
Greenwood Village, CO, US
Received
May 8, 2009
Decision date
October 14, 2009
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
MNW – Analyzer, Body Composition
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2770
Specialty
Cardiovascular

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Questions and answers

When was Electrofluidgraph cleared by the FDA?

Electrofluidgraph (K091369) received a 510(k) decision of Substantially Equivalent on October 14, 2009, 159 days after the submission was received.

What is the product code of K091369?

The FDA product code is MNW – Analyzer, Body Composition, a Class II (moderate risk) device regulated under 21 CFR 870.2770.