FDA 510(k) Application Details - K222340

Device Classification Name Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)

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510(K) Number K222340
Device Name Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Applicant Pulmonx Corporation
700 Chesapeake Road
Redwood City, CA 94063 US
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Contact Aniket Khakhadiya
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Regulation Number 868.5740

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Classification Product Code CBI
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Date Received 08/03/2022
Decision Date 12/01/2022
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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