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FDA 510(k)

HEMONIR TM

K-Number: K050014 · 2005-05-05

ApplicantNir Diagnostics, Inc.
Decision Date2005-05-05
Product CodeGLY
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMONIR TM is the device name listed in this FDA 510(k) record. The listed applicant is Nir Diagnostics, Inc.. It received FDA 510(k) clearance on 2005-05-05 under 510(k) number K050014. The device is classified under product code GLY. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMONIR TM?

HEMONIR TM is a medical device that received FDA 510(k) clearance on 2005-05-05. The listed applicant is Nir Diagnostics, Inc.. The 510(k) number is K050014.

When did HEMONIR TM receive FDA 510(k) clearance?

HEMONIR TM received FDA 510(k) clearance on 2005-05-05, under 510(k) number K050014.

Who is the listed applicant for HEMONIR TM?

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

What is the FDA product code for HEMONIR TM?

The FDA product code for HEMONIR TM is GLY.

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Related Devices (Code: GLY)

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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.

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