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FDA 510(k)

NMI IC

K-Number: K101326 · 2010-09-02

ApplicantNavilyst Medical, Inc.
Decision Date2010-09-02
Product CodeLJS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NMI IC is the device name listed in this FDA 510(k) record. The listed applicant is Navilyst Medical, Inc.. It received FDA 510(k) clearance on 2010-09-02 under 510(k) number K101326. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NMI IC?

NMI IC is a medical device that received FDA 510(k) clearance on 2010-09-02. The listed applicant is Navilyst Medical, Inc.. The 510(k) number is K101326.

When did NMI IC receive FDA 510(k) clearance?

NMI IC received FDA 510(k) clearance on 2010-09-02, under 510(k) number K101326.

Who is the listed applicant for NMI IC?

The FDA 510(k) record lists Navilyst Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NMI IC?

The FDA product code for NMI IC is LJS.

Other records listing Navilyst Medical, Inc. as applicant

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Related Devices (Code: LJS)

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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