510(k) K071642
- Device
- MEDIAID M960 SERIES, VITAL SIGNS MONITOR AND MEDIAID M900 SERIES, PULSE OXIMETER
- Applicant
- MEDIAID INC.
- 510(k) number
- K071642
- Product code
- DQA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-05-02
- Date received
- 2007-06-18
- Regulation
- 870.2700
- Classification name
- Oximeter
- Medical specialty
- Cardiovascular
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAYESH PATEL
- Address
- 17517 Fabrica Way, Suite H Cerritos CA US 90703 90703
FDA Registration Numbers#
- 3014389131
- 3015146106
- 3036754877
- 3027344406
- 3008830133
- 3016931915
- 3020460367
- 2112020
- 3003294644
- 3009001657
- 3010838917
- 3010381606
- 3010390468
- 3004009431
- 3001650535
- 3016678045
- 3008700497
- 1423537
- 3016939722
- 3036773433
- 3004906872
- 3013250653
- 2183613
- 1314417
- 3005798905
- 3003263092
- 3019944216
- 9610816
- 9680215
- 3024722701
- 9710602
- 3016170326
- 3003591740
- 3026960443
- 3034405508
- 3003687189
- 3015181391
- 2936999
- 3007307487
- 3021632375
- 3011191255
- 3026199641
- 3014766741
- 3010882708
- 3007420856
- 3012243264
- 3013426279
- 3020163307
- 3024512705
- 9614470
- 3038761440
- 3007858728
- 3021691064
- 2123774
- 3013652261
- 3006147705
- 3037341611
- 3015109923
- 3012494290
- 3017825461
- 3004149774
- 3017894657
- 2030624
- 3003971136
- 3013557562
- 3030446844
- 3014449259
- 2030745
- 3008573045
- 3042941992
- 3004016520
- 3009156722
- 3034603279
- 3012312061
- 3012678246
- 3003832357
- 1320894
- 1650907
- 3007305624
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 |
| 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#
summary
FDA Review#
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