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FDA 510(k)

NMI FC

K-Number: K091634 · 2010-03-01

ApplicantNavilyst Medical, Inc.
Decision Date2010-03-01
Product CodeDTL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NMI FC 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 2010-03-01 under 510(k) number K091634. The device is classified under product code DTL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NMI FC?

NMI FC is a medical device that received FDA 510(k) clearance on 2010-03-01. The listed applicant is Navilyst Medical, Inc.. The 510(k) number is K091634.

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

NMI FC received FDA 510(k) clearance on 2010-03-01, under 510(k) number K091634.

Who is the listed applicant for NMI FC?

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 FC?

The FDA product code for NMI FC is DTL.

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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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