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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Pulmonary Function Data
510(k) Number K945213
Device Name TEEN 100
Applicant
Aerosport, Inc.
3518 W. Liberty St.
Ann Arbor,  MI  48103
Applicant Contact ANDREW RAEDER
Correspondent
Aerosport, Inc.
3518 W. Liberty St.
Ann Arbor,  MI  48103
Correspondent Contact ANDREW RAEDER
Regulation Number868.1880
Classification Product Code
BZC  
Date Received10/25/1994
Decision Date 05/25/1995
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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