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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 K864719
Device Name PFLEX EM(TM) (EXERCISE MONITOR)
Applicant
HEALTH PRODUCTS, INC.
908 POMPTON AVE.
UNIT B2
CEDAR GROVE,  NJ  07009
Applicant Contact MARK J FLANICK
Correspondent
HEALTH PRODUCTS, INC.
908 POMPTON AVE.
UNIT B2
CEDAR GROVE,  NJ  07009
Correspondent Contact MARK J FLANICK
Regulation Number868.5690
Classification Product Code
BWF  
Date Received12/03/1986
Decision Date 03/16/1987
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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