510(k) K033876
- Device
- DOLPHIN 2000 OXIMETRY SENSORS, MODELS 2020, 2040, 2060, 2070, 2321, 2323, 2341, 2342, 2343, 2344, 2220, 2260 AND 2422
- Applicant
- DOLPHIN MEDICAL INC.
- 510(k) number
- K033876
- Product code
- DQA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-03-11
- Date received
- 2003-12-15
- 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
- BILL CURNAN
- Address
- 9433 S. Morning Glory Ln. Highlands Ranch CO US 80130 80130
FDA Registration Numbers#
- 3015181391
- 1423537
- 3010984687
- 3006636961
- 3003674698
- 1066270
- 9614683
- 3010827261
- 3010288146
- 3010834934
- 3015997711
- 3006125362
- 3008505660
- 9681377
- 3012977166
- 3003879246
- 3007358963
- 3004091281
- 2183613
- 3013652261
- 3013596024
- 3013500228
- 9610816
- 9680215
- 3015134004
- 1063285
- 3015697152
- 1217183
- 3009673645
- 3015109923
- 9617543
- 3008483389
- 9611031
- 3009617411
- 3013826848
- 2123774
- 3013426279
- 8030978
- 3008164770
- 3016931915
- 3037341611
- 3007413079
- 8010482
- 3021691064
- 3010838917
- 3030733800
- 3004415095
- 3005798905
- 1651104
- 3008830133
- 3011420269
- 3003971136
- 3016171841
- 3012104670
- 3011200896
- 3030149975
- 3010381606
- 3021559257
- 3012804266
- 3010536822
- 3012678246
- 3007607999
- 3013116677
- 3011353843
- 3032109181
- 3000126629
- 3004145393
- 3015967131
- 2939821
- 3007699081
- 3015455735
- 1713468
- 1054713
- 1000122786
- 3034603279
- 3009142030
- 2081040
- 3012337868
- 3030447506
Source Documents#
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 |
Legacy Summary#
summary
FDA Review#
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