510(k) K233956
- Device
- Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)
- Applicant
- Taiwan Aulisa Medical Devices Technologies, Inc.
- 510(k) number
- K233956
- Product code
- DQA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-01-30
- Date received
- 2023-12-15
- Regulation
- 870.2700
- Classification name
- Oximeter
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Ming Hsiu Hsiao
- Address
- 6f-2, # 3-1, Yuanqu St., Nangang Dist., Taipei City TW 115 115
FDA Registration Numbers
- 2030633
- 3011651103
- 1054713
- 3016170326
- 3015453963
- 3015109923
- 3016701404
- 3013188547
- 3004091281
- 1650347
- 3007607999
- 3030447506
- 3008395508
- 3010390468
- 3008716327
- 3012804266
- 1423537
- 9610861
- 3019944216
- 9617566
- 1063925
- 3014015501
- 3004102403
- 3015142815
- 3043513123
- 3010526986
- 3012733231
- 3012337868
- 3012302888
- 3018940143
- 3030733800
- 3015529350
- 3006182632
- 3017406171
- 1066270
- 3018514222
- 3013319212
- 3027510187
- 3007413079
- 3006552505
- 3015286931
- 3010984687
- 3008973759
- 3027256461
- 2134752
- 3007603826
- 2518422
- 3013116677
- 8010482
- 3014848734
- 3034603279
- 2936999
- 3014579161
- 3015542362
- 3007858728
- 3007048291
- 3024491912
- 3018685978
- 3011898560
- 3004485927
- 9610816
- 3008595074
- 3003263092
- 3030446844
- 3005873568
- 3011353843
- 3006636961
- 3017953405
- 3029906224
- 2032112
- 3016761372
- 3023412068
- 3012104670
- 3008505660
- 3024722701
- 9614470
- 3011790297
- 1219324
- 3023272766
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code DQA
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252655 | Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT) | Shenzhen Imdk Medical Technology Co., Ltd. | 2026-05-11 |
| K253887 | Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401) | Philips Medizin Systeme | 2026-05-01 |
| K260931 | Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R) | Unimed Medical Supplies, Inc. | 2026-04-14 |
| K252448 | AViTA Pulse Oximeter (SP61) | Avita Corporation | 2026-02-27 |
| K252805 | YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2026-02-17 |
| K253109 | Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O) | Shenzhen Best Electronics Co., Ltd. | 2026-01-07 |
| K251751 | Spo2 Sensor CSS032D | Shenzhen Ykd Technology Co., Ltd. | 2025-12-19 |
| K251696 | Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29) | Unimed Medical Supplies, Inc. | 2025-12-01 |
| K251691 | Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103-08) | Unimed Medical Supplies, Inc. | 2025-12-01 |
| K251695 | Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U203S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U103S-06) | Unimed Medical Supplies, Inc. | 2025-11-18 |
| K251693 | Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110-75); Unimed Reusable SpO2 Sensors (-75 Series) (U410S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U210S-75) | Unimed Medical Supplies, Inc. | 2025-11-18 |
| K250837 | Pulse Oximeter | Shanghai Berry Electronic Tech Co., Ltd. | 2025-09-25 |
| K250931 | Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U103-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U410-121); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U110-121) | Unimed Medical Supplies, Inc. | 2025-08-13 |
| K241086 | Avidhrt Sense SpO2 | Avidhrt, Inc. | 2025-05-09 |
| K242876 | Pulse Oximeter ( PO2, PO2A, PO2B) | Shenzhen Viatom Technology Co., Ltd. | 2025-02-28 |