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FDA 510(k)

ELECTROFLUIDGRAPH

K-Number: K091369 · 2009-10-14

ApplicantAkern USA, LLC
Decision Date2009-10-14
Product CodeMNW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ELECTROFLUIDGRAPH is the device name listed in this FDA 510(k) record. The listed applicant is Akern USA, LLC. It received FDA 510(k) clearance on 2009-10-14 under 510(k) number K091369. The device is classified under product code MNW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTROFLUIDGRAPH?

ELECTROFLUIDGRAPH is a medical device that received FDA 510(k) clearance on 2009-10-14. The listed applicant is Akern USA, LLC. The 510(k) number is K091369.

When did ELECTROFLUIDGRAPH receive FDA 510(k) clearance?

ELECTROFLUIDGRAPH received FDA 510(k) clearance on 2009-10-14, under 510(k) number K091369.

Who is the listed applicant for ELECTROFLUIDGRAPH?

The FDA 510(k) record lists Akern USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELECTROFLUIDGRAPH?

The FDA product code for ELECTROFLUIDGRAPH is MNW.

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Related Devices (Code: MNW)

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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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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