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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 K870835
Device Name ADULT APNEA MONITOR (20), MONITOR INTERFACE (30)
Applicant
APPLIED MEMBRANE TECHNOLOGY, INC.
11558 ENCORE CIRCLE
MINNETONKA,  MN  55343
Applicant Contact STEPHEN P CONOVER
Correspondent
APPLIED MEMBRANE TECHNOLOGY, INC.
11558 ENCORE CIRCLE
MINNETONKA,  MN  55343
Correspondent Contact STEPHEN P CONOVER
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received03/03/1987
Decision Date 03/27/1987
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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