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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 the device name listed in this FDA 510(k) record. The listed applicant is International Medical Industries, Inc.. It received FDA 510(k) clearance on 2020-12-16 under 510(k) 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. The listed applicant is International Medical Industries, Inc.. The 510(k) number is K201031.

When did NRFit® Caps, Male and Female Neuraxial Tip Caps receive FDA 510(k) clearance?

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

Who is the listed applicant for NRFit® Caps, Male and Female Neuraxial Tip Caps?

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

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.

Other records listing International Medical Industries, Inc. as applicant

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Related Devices (Code: QEH)

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.

K241385Omnifix Syringe NRFitB.Braun Medical, Inc.K213800Artiglass NRFitTM Tip L.O.R. Glass SyringesArtiglass SrlK192538BD Syringe NRFit Lok and BD Syringe NRFit SlipBecton, Dickinson and CompanyK181374NRFit SyringeJiangsu Caina Medical Co.,Ltd

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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