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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 K894556
Device Name SPIROTEQ
Applicant
System Analysis Corp.
Zone Industrielle - 13 Bis,
Rue Des Dames - 78340 Les
Clayes Sous Bois, France,  FR
Applicant Contact VERONIQUE BREIER
Correspondent
System Analysis Corp.
Zone Industrielle - 13 Bis,
Rue Des Dames - 78340 Les
Clayes Sous Bois, France,  FR
Correspondent Contact VERONIQUE BREIER
Regulation Number868.1840
Classification Product Code
BZG  
Date Received07/20/1989
Decision Date 01/09/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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