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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
Predetermined Change
Control Plan Authorized		 No
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