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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name spirometer, diagnostic
510(k) Number K842041
Device Name PULMONARY FUNCTION SYSTEM
Applicant
SENSOR MEDICS CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
SENSOR MEDICS CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.1840
Classification Product Code
BZG  
Date Received05/21/1984
Decision Date 06/15/1984
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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