EndoWave Infusion System— 510(k) K080392

Substantially Equivalent

Ekos Corp.

FDA 510(k) clearance K080392 for EndoWave Infusion System, Substantially Equivalent on 2008-04-30. Applicant: Ekos Corp..

Clearance details

Applicant: Ekos Corp.
Product code: Code QEY
Advisory panel: Cardiovascular
Date received: 2008-02-13
Decision date: 2008-04-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Bothell, WA, US

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