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FDA 510(k)

NRFit® Caps, Male and Female Neuraxial Tip Caps

K-Number: K201031 · 2020-12-16

ApplicantInternational Medical Industries, Inc.
Decision Date2020-12-16
Product CodeQEH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NRFit® Caps, Male and Female Neuraxial Tip Caps is a medical device manufactured by International Medical Industries, Inc.. It received FDA 510(k) clearance on 2020-12-16 under approval number K201031. The device is classified under product code QEH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NRFit® Caps, Male and Female Neuraxial Tip Caps?

NRFit® Caps, Male and Female Neuraxial Tip Caps is a medical device that received FDA 510(k) clearance on 2020-12-16. It is manufactured by International Medical Industries, Inc.. The 510(k) number is K201031.

When was NRFit® Caps, Male and Female Neuraxial Tip Caps approved by the FDA?

NRFit® Caps, Male and Female Neuraxial Tip Caps received FDA 510(k) clearance on 2020-12-16, under approval number K201031.

What company makes NRFit® Caps, Male and Female Neuraxial Tip Caps?

NRFit® Caps, Male and Female Neuraxial Tip Caps is manufactured by International Medical Industries, Inc..

What is the FDA product code for NRFit® Caps, Male and Female Neuraxial Tip Caps?

The FDA product code for NRFit® Caps, Male and Female Neuraxial Tip Caps is QEH.

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Related Devices (Code: QEH)

K181374NRFit SyringeJiangsu Caina Medical Co.,Ltd K192538BD Syringe NRFit Lok and BD Syringe NRFit SlipBecton, Dickinson and Company K213800Artiglass NRFitTM Tip L.O.R. Glass SyringesArtiglass Srl K241385Omnifix Syringe NRFitB.Braun Medical, Inc.

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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