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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Predicted Values, Pulmonary Function
510(k) Number K000648
Device Name SPIRO PRO
Applicant
Erich Jaeger GmbH
22705 Savi Ranch Pkwy.
Yorba Linda,  CA  92887
Applicant Contact LARRY MURDOCK
Correspondent
Erich Jaeger GmbH
22705 Savi Ranch Pkwy.
Yorba Linda,  CA  92887
Correspondent Contact LARRY MURDOCK
Regulation Number868.1890
Classification Product Code
BTY  
Date Received02/28/2000
Decision Date 03/29/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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