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510(k) K050014

HEMONIR TM by Nir Diagnostics, Inc. — Product Code GLY

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 5, 2005
Date Received: January 3, 2005
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Oximeter To Measure Hemoglobin
Device Class: Class II
Regulation Number: 864.7500
Review Panel: HE
Submission Type