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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, breathing frequency
510(k) Number K900826
Device Name 'APNEA-ELECTRODE'
Applicant
MEDICAL SCIENCE PRODUCTS, INC.
P.0.BOX 381
CANAL FULTON,  OH  44614
Applicant Contact GARY SMITH
Correspondent
MEDICAL SCIENCE PRODUCTS, INC.
P.0.BOX 381
CANAL FULTON,  OH  44614
Correspondent Contact GARY SMITH
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received02/21/1990
Decision Date 04/26/1990
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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