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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 K941759
Device Name SNORING SENSOR
Applicant
EPM DEVELOPMENT SYSTEMS CORP.
5212 HIGHBERRY WOODS RD.
MIDLOTHIAN,  VA  23112
Applicant Contact STEPHEN A BURTON
Correspondent
EPM DEVELOPMENT SYSTEMS CORP.
5212 HIGHBERRY WOODS RD.
MIDLOTHIAN,  VA  23112
Correspondent Contact STEPHEN A BURTON
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received03/10/1994
Decision Date 11/10/1994
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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