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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
Predetermined Change
Control Plan Authorized		 No
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