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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Meter, Peak Flow, Spirometry
510(k) Number K050853
Device Name PMP4 SPIROPRO
Applicant
Card Guard Scientific Survival , Ltd.
2 Pekeris St.
Rehovot,  IL 76100
Applicant Contact NA'AMA OREN
Correspondent
Card Guard Scientific Survival , Ltd.
2 Pekeris St.
Rehovot,  IL 76100
Correspondent Contact NA'AMA OREN
Regulation Number868.1860
Classification Product Code
BZH  
Date Received04/04/2005
Decision Date 05/04/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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