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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 K905421
Device Name EXIT ALARM
Applicant
Alertcare
Shelterpoint Business Center
591 Redwood Hwy. Suite 2125
Mill Valley,  CA  94941
Applicant Contact TOM J COWLEY
Correspondent
Alertcare
Shelterpoint Business Center
591 Redwood Hwy. Suite 2125
Mill Valley,  CA  94941
Correspondent Contact TOM J COWLEY
Regulation Number880.2400
Classification Product Code
KMI  
Date Received12/04/1990
Decision Date 02/12/1991
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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