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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 K911386
Device Name SLEEPMASTER
Applicant
Biomedical Monitoring Systems, Inc.
C/O Rjl & Associates
13 Enid Ln.
East Lyme,  CT  06333
Applicant Contact RONALD LUICH
Correspondent
Biomedical Monitoring Systems, Inc.
C/O Rjl & Associates
13 Enid Ln.
East Lyme,  CT  06333
Correspondent Contact RONALD LUICH
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received03/28/1991
Decision Date 04/24/1992
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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