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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 K901330
Device Name THE MONITOR ELECTRONIC BED ALARM SYSTEM
Applicant
The Monitor Corp.
5757 Alpha Rd. #304
Dallas,  TX  75240
Applicant Contact T. H PARKE
Correspondent
The Monitor Corp.
5757 Alpha Rd. #304
Dallas,  TX  75240
Correspondent Contact T. H PARKE
Regulation Number880.2400
Classification Product Code
KMI  
Date Received03/22/1990
Decision Date 08/30/1990
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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