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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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More FDA Info for this Product Code
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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