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510(k) K231506

Current Health System by Current Health , Ltd. — Product Code MSX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 2023
Date Received
May 24, 2023
Clearance Type
Special
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 Current Health , Ltd.

  • K222550 — Current Health System (November 1, 2022)
  • K210133 — Current Health Monitoring System Gen 2 (G2) (September 3, 2021)
  • K191272 — Wearable Device, Wearable Package (July 12, 2019)
  • K190073 — Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry (March 27, 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)
  • K233418 — Biofourmis Everion+ (G2) (May 9, 2024)
  • K232548 — Corsano CardioWatch 287-2 System (March 22, 2024)
  • K223567 — CNS-2101 Central Monitor (July 31, 2023)
  • K213863 — Everion+ System (February 23, 2023)