510(k) K912880
- Device
- VITALMAX 510/520
- Applicant
- PACE TECH, INC.
- 510(k) number
- K912880
- Product code
- DQA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-11-14
- Date received
- 1991-07-01
- Regulation
- 870.2700
- Classification name
- Oximeter
- Medical specialty
- Cardiovascular
- Review panel
- Anesthesiology
- Clearance type
- Traditional
- Third party reviewed
- No
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#
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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