510(k) K962127
- Device
- OHMEDA 3800 PULSE OXIMETER
- Applicant
- OHMEDA MEDICAL
- 510(k) number
- K962127
- Product code
- DQA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-10-10
- Date received
- 1996-06-03
- 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
- CHARLES MORREALE
- Address
- Ohmeda Dr. P.O. Box 7550 Madison WI US 53707 53707
FDA Registration Numbers#
- 3008717264
- 3010852191
- 3000206696
- 3003263092
- 2016493
- 3010071455
- 3006713849
- 3007583504
- 3011420269
- 3010419931
- 3008058135
- 3015997711
- 2081040
- 3021691064
- 9614470
- 3014506106
- 3031158
- 3011353016
- 1063285
- 3022418645
- 3024512705
- 3038185755
- 3014579161
- 3009247326
- 2025816
- 3013652261
- 3019470217
- 2123774
- 3004009431
- 1054713
- 3015134004
- 3035111606
- 3010082909
- 3006979678
- 3005798905
- 9614683
- 1219324
- 3013826848
- 3011782009
- 3027222147
- 3004016520
- 3043479346
- 3011721071
- 3003971136
- 1320360
- 3005569927
- 3013426279
- 3012302888
- 3012348571
- 9617286
- 3038429306
- 1650907
- 3012312061
- 3014652024
- 3016859940
- 3032391
- 3013729860
- 3026998289
- 3010288146
- 1220908
- 9610105
- 3012494290
- 3034603279
- 3009617411
- 3037341611
- 1000589001
- 3016701404
- 3013513377
- 3009241523
- 3014848734
- 3037007069
- 3011191255
- 3011359729
- 3009551875
- 1423537
- 3013896610
- 3044675072
- 1217183
- 3012678246
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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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