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510(k) K202497

Aulisa Multiple Patient Digital Vital Sign Monitoring System by Taiwan Aulisa Medical Devices Technologies, Inc. — Product Code MSX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2020
Date Received
August 31, 2020
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 Taiwan Aulisa Medical Devices Technologies, Inc.

  • K233963 — Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) (February 25, 2025)
  • K233956 — Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018) (January 30, 2025)
  • K240220 — Aulisa Temperature Module (TM0002) (September 27, 2024)
  • K203208 — Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (June 12, 2022)
  • K191207 — Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System (June 25, 2019)
  • K183067 — Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System (March 1, 2019)
  • K182822 — Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System (March 1, 2019)
  • K162580 — Guardian Angel GA1000 Digital Vital Sign Monitoring System (March 3, 2017)

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