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Taiwan Aulisa Medical Devices Technologies, Inc.

FDA 510(k) & PMA Approved Devices — 9 products

Total Devices9
Categories3
Latest FDA decision2025-02-25
TypeNumberDevice NameCodeDateActions
510(k) K233963 Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)DQA2025-02-25 View
510(k) K233956 Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)DQA2025-01-30 View
510(k) K240220 Aulisa Temperature Module (TM0002)FLL2024-09-27 View
510(k) K203208 Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring SystemDQA2022-06-12 View
510(k) K202497 Aulisa Multiple Patient Digital Vital Sign Monitoring SystemMSX2020-10-30 View
510(k) K191207 Guardian Angel Rx GA2001 Digital Vital Sign Monitoring SystemDQA2019-06-25 View
510(k) K182822 Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring SystemDQA2019-03-01 View
510(k) K183067 Guardian Angel Rx GA2000 Digital Vital Sign Monitoring SystemDQA2019-03-01 View
510(k) K162580 Guardian Angel GA1000 Digital Vital Sign Monitoring SystemDQA2017-03-03 View