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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 K841392
Device Name BIOMATT-1
Applicant
BIOREC US, INC.
P.O. BOX 1116
LAGRANGE PARK,  IL  60525 -
Applicant Contact PETER MERTENS
Correspondent
BIOREC US, INC.
P.O. BOX 1116
LAGRANGE PARK,  IL  60525 -
Correspondent Contact PETER MERTENS
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received04/03/1984
Decision Date 01/18/1985
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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