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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Exerciser, Powered
510(k) Number K890607
Device Name SUTTER HOSPITAL CPM
Applicant
Sutter Corp.
9425 Chesapeake Dr.
San Diego,  CA  92123
Applicant Contact H MIZOGUCHI
Correspondent
Sutter Corp.
9425 Chesapeake Dr.
San Diego,  CA  92123
Correspondent Contact H MIZOGUCHI
Regulation Number890.5380
Classification Product Code
BXB  
Date Received02/06/1989
Decision Date 02/27/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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