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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Bed Patient
510(k) Number K901969
Device Name ALERT BED ALARM SYSTEM
Applicant
Alertronics, Inc.
P.O. Box 35446
Tulsa,  OK  74153
Applicant Contact RON WOOD
Correspondent
Alertronics, Inc.
P.O. Box 35446
Tulsa,  OK  74153
Correspondent Contact RON WOOD
Regulation Number880.2400
Classification Product Code
KMI  
Date Received05/01/1990
Decision Date 09/12/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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