FDA 510(k) Application Details - K203473

Device Classification Name Plethysmograph, Impedance

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510(K) Number K203473
Device Name Plethysmograph, Impedance
Applicant ImpediMed Limited
Unit 1, 50 Parker Court
Pinkenba 4008 AU
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Contact Catherine Kingsford
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Regulation Number 870.2770

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Classification Product Code DSB
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Date Received 11/25/2020
Decision Date 04/19/2021
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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