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510(k) K161164

CareEvent inclusive of the CareEvent Mobile Application accessory by Philips Medical Systems — Product Code MSX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 2016
Date Received
April 25, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Network And Communication, Physiological Monitors
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

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  • K232548 — Corsano CardioWatch 287-2 System (March 22, 2024)
  • K231506 — Current Health System (August 24, 2023)
  • K223567 — CNS-2101 Central Monitor (July 31, 2023)