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FDA 510(k)

NEUROWAVE MICRO-INFUSION SYSTEM

K-Number: K062508 · 2006-12-05

ApplicantEkos Corp.
Decision Date2006-12-05
Product CodeNUI
Advisory CommitteeCV
DecisionUnknown

Device Summary

NEUROWAVE MICRO-INFUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ekos Corp.. It received FDA 510(k) clearance on 2006-12-05 under 510(k) number K062508. The device is classified under product code NUI. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the NEUROWAVE MICRO-INFUSION SYSTEM?

NEUROWAVE MICRO-INFUSION SYSTEM is a medical device that received FDA 510(k) clearance on 2006-12-05. The listed applicant is Ekos Corp.. The 510(k) number is K062508.

When did NEUROWAVE MICRO-INFUSION SYSTEM receive FDA 510(k) clearance?

NEUROWAVE MICRO-INFUSION SYSTEM received FDA 510(k) clearance on 2006-12-05, under 510(k) number K062508.

Who is the listed applicant for NEUROWAVE MICRO-INFUSION SYSTEM?

The FDA 510(k) record lists Ekos Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEUROWAVE MICRO-INFUSION SYSTEM?

The FDA product code for NEUROWAVE MICRO-INFUSION SYSTEM is NUI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Ekos Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K081467EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATIONK080392EndoWave Infusion SystemK073166ENDOWAVE INFUSION SYSTEMK072507ENDOWAVE INFUSION SYSTEMK071933ENDOWAVE INFUSION SYSTEMK063620EKOS MICRO-INFUSION SYSTEM

View all 23 devices →

Related Devices (Code: NUI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K053437EKOS MICRO-INFUSION SYSTEMEkos Corp.K051225EKOS MICRO-INFUSION SYSTEMEkos Corp.K041826EKOS ULTRASOUND INFUSION SYSTEMEkos Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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