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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K944961
Device Name PERSONAL ALARM SYSTEM (PAS)
Applicant
Cytoprobe Corp.
9191 Towne Cenre Dr.,
Suite 430
San Diego,  CA  92122
Applicant Contact JOHN ZABSKY
Correspondent
Cytoprobe Corp.
9191 Towne Cenre Dr.,
Suite 430
San Diego,  CA  92122
Correspondent Contact JOHN ZABSKY
Classification Product Code
LDQ
Date Received10/07/1994
Decision Date 08/07/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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