FDA 510(k) Application Details - K944961

Device Classification Name

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510(K) Number K944961
Device Name PERSONAL ALARM SYSTEM (PAS)
Applicant CYTOPROBE CORP.
9191 TOWNE CENRE DRIVE,
SUITE 430
SAN DIEGO, CA US
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Contact JOHN ZABSKY
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Regulation Number

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Classification Product Code LDQ
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Date Received 10/07/1994
Decision Date 08/07/1995
Decision SE - Substantially Equivalent
Classification Advisory Committee HO - General Hospital
Review Advisory Committee -
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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