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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System Accessories, Extracorporeal
510(k) Number K831402
Device Name PRESSURE MONITOR & CONTROL UNIT APC-02A
Applicant
Parker Hannifin Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Parker Hannifin Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number876.5820
Classification Product Code
KXM  
Date Received05/02/1983
Decision Date 08/08/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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