Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)
Taiwan Aulisa Medical Devices Technologies, Inc. · Cardiovascular
Open FDA's page for this record- Third party flag
- N
- City
- Taipei City
- Advisory committee description
- Cardiovascular
- Address 1
- 6f-2, # 3-1, Yuanqu St., Nangang Dist.,
- Statement or summary
- Summary
- Product code
- DQA
- Zip code
- 115
- Applicant
- Taiwan Aulisa Medical Devices Technologies, Inc.
- Decision date
- 2025-02-25
- Decision code
- SESE
- Country code
- TW
- Device name
- Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)
- Advisory committee
- CV
- Contact
- Ming Hsiu Hsiao
- K number
- K233963
- Date received
- 2023-12-15
- Review advisory committee
- AN
- Postal code
- 115
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Oximeter
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.2700
- Device class
- 2
- Registration number
- 3044675072, 3010526986, 3017953522, 3003965134, 3008729547, 3006713849, 3003589956, 2029015, 3012302888, 1314417, 3010390468, 3016674095, 3014541700, 3009156722, 3024512705, 3007699081, 3016170326, 3003622639, 3043513123, 9614500, 3013896610, 3014856521, 3013679558, 3032948391, 3007307487, 2434008, 3014848734, 3004091281, 9610816, 3032391, 2025816, 9617566, 3003971136, 2022648, 3008483389, 3038761440, 8020893, 8021084, 3007603826, 3012933969 +357 more
- FEI number
- 3044675072, 3010526986, 3017953522, 3003965134, 3008729547, 3006713849, 3003589956, 3012302888, 1000292048, 1314417, 3010390468, 3016674095, 3014541700, 3009156722, 3024512705, 3007699081, 3016170326, 3003622639, 3043513123, 3013896610, 3014856521, 3013679558, 3003794634, 3032948391, 3007307487, 2434008, 3014848734, 2025816, 3003971136, 2022648, 3006254866, 3002663379, 3008483389, 3038761440, 3007603826, 3012933969, 3014233600, 3013596024, 3010082909, 3003630387 +357 more