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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Conduction, Anesthetic (W/Wo Introducer)
510(k) Number K192914
Device Name Stimuplex Onvision System
Applicant
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best,  NL 5684 PC
Applicant Contact Gert de Vries
Correspondent
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best,  NL 5684 PC
Correspondent Contact Gert de Vries
Regulation Number868.5150
Classification Product Code
BSP  
Subsequent Product Code
IYO  
Date Received10/15/2019
Decision Date 05/27/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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