Bci M4529A Oem Digital Handheld Oximeter, Model M4529A
FDA 510(k) K001770 · Bci, Inc.
510(k) numberK001770
Submission
- Device name
- Bci M4529A Oem Digital Handheld Oximeter, Model M4529A
- Applicant
- Bci, Inc.
Waukesha, WI, US - Received
- June 12, 2000
- Decision date
- July 5, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQA – Oximeter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2700
- Specialty
- Cardiovascular
Other 510(k)s with product code DQA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252821 | Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m)…DQA · Traditional | Philips Medizin Systeme Böblingen GmbH | 05/29/2026SE |
| K252655 | Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO…DQA · Traditional | Shenzhen Imdk Medical Technology Co., Ltd. | 05/11/2026SE |
| K253887 | Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar…DQA · Traditional | Philips Medizin Systeme | 05/01/2026SE |
| K260931 | Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)DQA · Special | Unimed Medical Supplies, Inc. | 04/14/2026SE |
| K252448 | AViTA Pulse Oximeter (SP61)DQA · Traditional | Avita Corporation | 02/27/2026SE |
| K252805 | YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)DQA · Traditional | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 02/17/2026SE |
| K253109 | Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)DQA · Traditional | Shenzhen Best Electronics Co., Ltd. | 01/07/2026SE |
| K251751 | Spo2 Sensor CSS032DDQA · Traditional | Shenzhen Ykd Technology Co., Ltd. | 12/19/2025SE |
| K251696 | Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2…DQA · Traditional | Unimed Medical Supplies, Inc. | 12/01/2025SE |
| K251691 | Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08…DQA · Traditional | Unimed Medical Supplies, Inc. | 12/01/2025SE |
More from Unimed Medical Supplies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K030407 | Advisor, Model 9200CCK · Traditional | 08/19/2003SE |
| K031742 | Bci 6004 Nibp Monitor with Nellcor Pulse OximeterDQA · Traditional | 08/18/2003SE |
| K020739 | Bci 3178 Pediatric Pulse Oximetry SensorDQA · Traditional | 06/03/2002SE |
| K020350 | Bci 3180 Pulse OximeterDQA · Traditional | 04/30/2002SE |
| K013862 | Bci 1621 Oximetry Data Management ProgramDQA · Traditional | 02/21/2002SE |
| K013171 | 3420 Digit Pulse Oximeter, Model 3420DQA · Traditional | 01/03/2002SE |
| K011156 | Bci 3403 Sleep Screening Pulse OximeterDQA · Traditional | 06/14/2001SE |
| K010770 | Bci Advisor Vital Signs Monitor (9200)MWI · Traditional | 06/12/2001SE |
| K011177 | Bci Advisor Vital Signs Monitor (9200)DPS · Traditional | 05/23/2001SE |
| K944121 | Sharps Container 18 GallonFMI · Traditional | 01/27/1995SE |
Questions and answers
When was Bci M4529A Oem Digital Handheld Oximeter, Model M4529A cleared by the FDA?
Bci M4529A Oem Digital Handheld Oximeter, Model M4529A (K001770) received a 510(k) decision of Substantially Equivalent on July 5, 2000, 23 days after the submission was received.
What is the product code of K001770?
The FDA product code is DQA – Oximeter, a Class II (moderate risk) device regulated under 21 CFR 870.2700.