FDA 510(k)

NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML

K-Number: K113198 · 2011-11-28

Decision Date2011-11-28

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML 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 2011-11-28 under 510(k) number K113198. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML?

NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML is a medical device that received FDA 510(k) clearance on 2011-11-28. The listed applicant is Navilyst Medical, Inc.. The 510(k) number is K113198.

When did NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML receive FDA 510(k) clearance?

NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML received FDA 510(k) clearance on 2011-11-28, under 510(k) number K113198.

Who is the listed applicant for NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML?

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 CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML?

The FDA product code for NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML is DXT.

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Official Source

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