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510(k) K190073

Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub by Current Health , Ltd. — Product Code MSX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2019
Date Received
January 16, 2019
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 Current Health , Ltd.

  • K231506 — Current Health System (August 24, 2023)
  • 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)

Other clearances for product code MSX

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  • 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)
  • K231506 — Current Health System (August 24, 2023)
  • K223567 — CNS-2101 Central Monitor (July 31, 2023)