510(k) K093881
- Device
- TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSOR
- Applicant
- GE HEALTHCARE FINLAND OY
- 510(k) number
- K093881
- Product code
- DQA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-03-12
- Date received
- 2009-12-18
- Regulation
- 870.2700
- Classification name
- Oximeter
- Medical specialty
- Cardiovascular
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- TOMMI JOKINIEMI
- Address
- Kuortaneenkatu 2 Helsinki FI FIN-00510 FIN-00510
FDA Registration Numbers#
- 3011420269
- 3013689228
- 3007662958
- 3012977166
- 3013500228
- 3032391
- 3014848734
- 3012251275
- 3015453963
- 3023272766
- 3012359877
- 2030624
- 3034405508
- 3011200896
- 3021559257
- 3012797688
- 3020018
- 3007603826
- 8021084
- 3003630387
- 3016998644
- 3043668257
- 3014766741
- 3003971136
- 3016931915
- 3013426279
- 3008570547
- 3003965134
- 3018783553
- 3016426850
- 3008058135
- 3029871637
- 1000589001
- 9615102
- 3011191255
- 3032109181
- 3008363989
- 3015007456
- 3004415095
- 3017422354
- 3037007069
- 3011713222
- 1419898
- 3016661538
- 3009617411
- 3032948391
- 1713468
- 3005873568
- 3004906872
- 3017500903
- 3011065399
- 3013557562
- 3009139884
- 3006636961
- 3007413079
- 3005783425
- 3009247326
- 3029906224
- 3006463573
- 3010834934
- 1417592
- 3010157426
- 3009831876
- 3009241523
- 1066270
- 3012312061
- 3012804266
- 3012238587
- 3001421318
- 3015142815
- 8022257
- 3021632375
- 9611031
- 3009077524
- 3010317211
- 3026740087
- 3022418645
- 3005380088
- 2030745
Source Documents#
Other 510(k) Records For Product Code DQA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252821 | Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T) | Philips Medizin Systeme Böblingen GmbH | 2026-05-29 |
| 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 |
Legacy Summary#
summary
FDA Review#
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