510(k) K122927
- Device
- OXICARE FINGERTIP PULSE OXIMETER
- Applicant
- DELBIO INCORPORATED
- 510(k) number
- K122927
- Product code
- DQA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-12-20
- Date received
- 2012-09-24
- Regulation
- 870.2700
- Classification name
- Oximeter
- Medical specialty
- Cardiovascular
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- NICKY PAN
- Address
- 3f & 6f, No 252 Shangying Rd. Taoyuan County Guishan Industrial Zone TW 33341 33341
FDA Registration Numbers#
- 3009831876
- 3010852191
- 3023272766
- 3005798905
- 3010427901
- 3014461810
- 3003832357
- 3009142030
- 2518422
- 3026585241
- 3013188547
- 3000279201
- 3011167030
- 3032948391
- 3014506106
- 3044156918
- 1058397
- 3003294644
- 3004149774
- 3009617411
- 1000589001
- 2030633
- 3002721930
- 3009607734
- 3012348571
- 1217183
- 3014541700
- 3043668257
- 3010317211
- 3001421318
- 3019944216
- 3020018
- 3016859940
- 3016674095
- 3010834934
- 3006552505
- 3029906224
- 3000206696
- 3009327812
- 3003741676
- 3004009431
- 3038185755
- 3015997711
- 3037007069
- 3003630387
- 3016939722
- 3010703925
- 3010157426
- 3019388613
- 3013783488
- 3016171841
- 3009001657
- 3015876
- 9710602
- 3021131596
- 3016170326
- 3013418500
- 1314417
- 3007134734
- 2030745
- 3023412068
- 3007607999
- 3008361498
- 1924066
- 3012494290
- 3017953522
- 1320894
- 3012251275
- 3010882708
- 2011171
- 9610105
- 2112020
- 3005873568
- 3009191551
- 3005569927
- 3003263092
- 3021559257
- 3013826848
- 3026960443
- 3018514222
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases