EKOS MICRO-INFUSION SYSTEM— 510(k) K053437

Substantially Equivalent

Ekos Corp.

FDA 510(k) clearance K053437 for EKOS MICRO-INFUSION SYSTEM, Substantially Equivalent on 2006-01-06. Applicant: Ekos Corp.. Device class: 2.

Clearance details

Applicant: Ekos Corp.
Product code: Code NUI
Device class: Class 2
Regulation: 21 CFR 870.1200
Advisory panel: Cardiovascular
Date received: 2005-12-09
Decision date: 2006-01-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Bothell, WA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NUI

K062508 — NEUROWAVE MICRO-INFUSION SYSTEM2006-12-05
K051225 — EKOS MICRO-INFUSION SYSTEM2005-06-10
K041826 — EKOS ULTRASOUND INFUSION SYSTEM2005-04-27

More clearances from Ekos Corp.

K081467 — EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION2008-06-26
K080392 — EndoWave Infusion System2008-04-30
K073166 — ENDOWAVE INFUSION SYSTEM2008-04-22
K072507 — ENDOWAVE INFUSION SYSTEM2007-10-04
K071933 — ENDOWAVE INFUSION SYSTEM2007-08-10

Data sourced from openFDA. This site is unofficial and independent of the FDA.