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510(k) K191876

PulmoScan by Cognita Labs, LLC — Product Code PNV

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 18, 2020
Date Received: July 15, 2019
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Impedance Measuring Device Utilizing Oscillation Techniques
Device Class: Class II
Regulation Number: 868.1840
Review Panel: AN
Submission Type

This device measures respiratory impedance.