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510(k) K242842

ANNE View, Central Hub by Sibel Health, Inc. — Product Code MSX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2025
Date Received
September 19, 2024
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 Sibel Health, Inc.

  • K253021 — ANNE Maternal (February 26, 2026)
  • K240251 — ANNE Chest (June 3, 2024)
  • K240305 — ANNE Limb (May 28, 2024)
  • K223711 — ANNE One (August 10, 2023)

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)
  • 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)
  • K213863 — Everion+ System (February 23, 2023)