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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Monitoring (W/Wo Alarm)
510(k) Number K051279
Device Name CALDYNE, INC. EXHALOMETER EX100, MODEL EX100
Applicant
CALDYNE, INC.
29201 VIA NORTE
TEMECULA,  CA  92591
Applicant Contact TOM SHANKS
Correspondent
CALDYNE, INC.
29201 VIA NORTE
TEMECULA,  CA  92591
Correspondent Contact TOM SHANKS
Regulation Number868.1850
Classification Product Code
BZK  
Subsequent Product Code
CAH  
Date Received05/17/2005
Decision Date 09/07/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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