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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Therapeutic (Incentive)
510(k) Number K820528
Device Name PFLEX TM
Applicant
HEALTHSCAN, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
HEALTHSCAN, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5690
Classification Product Code
BWF  
Date Received03/01/1982
Decision Date 03/26/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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