FDA 510(k) Application Details - K020102

Device Classification Name Spirometer, Diagnostic

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510(K) Number K020102
Device Name Spirometer, Diagnostic
Applicant IQTEQ DEVELOPMENT
JAGA HOSE, 61 WALE ST.
CAPE TOWN, WESTERN CAPE 8001 ZA
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Contact RAY WRIGHT
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Regulation Number 868.1840

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Classification Product Code BZG
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Date Received 01/11/2002
Decision Date 03/21/2003
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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