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FDA 510(k)

NU-SITE

K-Number: K943897 · 1995-02-10

ApplicantMedex, Inc.
Decision Date1995-02-10
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NU-SITE is the device name listed in this FDA 510(k) record. The listed applicant is Medex, Inc.. It received FDA 510(k) clearance on 1995-02-10 under 510(k) number K943897. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NU-SITE?

NU-SITE is a medical device that received FDA 510(k) clearance on 1995-02-10. The listed applicant is Medex, Inc.. The 510(k) number is K943897.

When did NU-SITE receive FDA 510(k) clearance?

NU-SITE received FDA 510(k) clearance on 1995-02-10, under 510(k) number K943897.

Who is the listed applicant for NU-SITE?

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

What is the FDA product code for NU-SITE?

The FDA product code for NU-SITE is FPA.

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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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