510(k) K192914

Stimuplex Onvision System by Philips Medical Systems Nederland B.V. — Product Code BSP

K192914 is an FDA 510(k) premarket notification submitted by Philips Medical Systems Nederland B.V. for the device "Stimuplex Onvision System". The FDA issued a decision of Substantially Equivalent on May 27, 2020. The device falls under product code BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)), a Class II device regulated under 21 CFR 868.5150. Philips Medical Systems Nederland B.V. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 2020
Date Received
October 15, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Conduction, Anesthetic (W/Wo Introducer)
Device Class
Class II
Regulation Number
868.5150
Review Panel
AN
Submission Type