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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name spirometer, diagnostic
510(k) Number K020102
Device Name IQTEQ SPIROMETER
Applicant
IQTEQ DEVELOPMENT
JAGA HOSE, 61 WALE ST.
CAPE TOWN, WESTERN CAPE,  ZA 8001
Applicant Contact RAY WRIGHT
Correspondent
IQTEQ DEVELOPMENT
JAGA HOSE, 61 WALE ST.
CAPE TOWN, WESTERN CAPE,  ZA 8001
Correspondent Contact RAY WRIGHT
Regulation Number868.1840
Classification Product Code
BZG  
Subsequent Product Codes
BTY   BZC   BZM  
Date Received01/11/2002
Decision Date 03/21/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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