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510(k) K233956

Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018) by Taiwan Aulisa Medical Devices Technologies, Inc. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2025
Date Received
December 15, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
Submission Type

Other clearances by Taiwan Aulisa Medical Devices Technologies, Inc.

  • K233963 — Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) (February 25, 2025)
  • K240220 — Aulisa Temperature Module (TM0002) (September 27, 2024)
  • K203208 — Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (June 12, 2022)
  • K202497 — Aulisa Multiple Patient Digital Vital Sign Monitoring System (October 30, 2020)
  • K191207 — Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System (June 25, 2019)
  • K182822 — Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System (March 1, 2019)
  • K183067 — Guardian Angel Rx GA2000 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 DQA

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  • K252805 — YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) (February 17, 2026)
  • K253109 — Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O) (January 7, 2026)
  • K251751 — Spo2 Sensor CSS032D (December 19, 2025)
  • K251696 — Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusa (December 1, 2025)
  • K251691 — Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Senso (December 1, 2025)
  • K251695 — Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Senso (November 18, 2025)
  • K251693 — Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensor (November 18, 2025)
  • K250837 — Pulse Oximeter (September 25, 2025)
  • K250931 — Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable (August 13, 2025)