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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 K840418
Device Name INSPIRATORY/EXPIRATORY MUSCLE EXERCIS
Applicant
INSPIRON CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
INSPIRON CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5690
Classification Product Code
BWF  
Date Received01/31/1984
Decision Date 02/17/1984
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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