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510(k) K233418

Biofourmis Everion+ (G2) by Biofourmis Singapore Pte., Ltd. — Product Code MSX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2024
Date Received
October 10, 2023
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

Other clearances by Biofourmis Singapore Pte., Ltd.

  • K213863 — Everion+ System (February 23, 2023)
  • K183282 — Biovitals Analytics Engine (August 15, 2019)
  • K182344 — RhythmAnalytics (March 7, 2019)

Other clearances for product code MSX

  • K243270 — TigerConnect Alarm Management (September 30, 2025)
  • K242728 — BeneVision Central Monitoring System (July 31, 2025)
  • K242750 — Central Station (June 5, 2025)
  • K242842 — ANNE View, Central Hub (January 8, 2025)
  • K241397 — Hinscope (November 14, 2024)
  • K233834 — Infinity Gateway Suite (July 12, 2024)
  • K232548 — Corsano CardioWatch 287-2 System (March 22, 2024)
  • K231506 — Current Health System (August 24, 2023)
  • K223567 — CNS-2101 Central Monitor (July 31, 2023)
  • K213863 — Everion+ System (February 23, 2023)