510(k) K954267
- Device
- BURDICK 200 PULSE OXIMETER
- Applicant
- BURDICK, INC.
- 510(k) number
- K954267
- Product code
- DQA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-05-03
- Date received
- 1995-09-12
- 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
- PAUL E APPEL
- Address
- 15 Plumb St. Miltoon WI US 53563 53563
FDA Registration Numbers#
- 3044675072
- 3010526986
- 3017953522
- 3003965134
- 3008729547
- 3006713849
- 3003589956
- 2029015
- 3012302888
- 1314417
- 3010390468
- 3016674095
- 3014541700
- 3009156722
- 3024512705
- 3007699081
- 3016170326
- 3003622639
- 3043513123
- 9614500
- 3013896610
- 3014856521
- 3013679558
- 3032948391
- 3007307487
- 2434008
- 3014848734
- 3004091281
- 9610816
- 3032391
- 2025816
- 9617566
- 3003971136
- 2022648
- 3008483389
- 3038761440
- 8020893
- 8021084
- 3007603826
- 3012933969
- 3002736372
- 3014233600
- 3013596024
- 3010082909
- 3003630387
- 3009142030
- 3018783526
- 3014766741
- 3009077524
- 3034405508
- 2016493
- 2030633
- 1713468
- 3014652024
- 9614860
- 3009831876
- 3006182632
- 1063285
- 3008570547
- 3013689228
- 3024379416
- 3006240053
- 2030624
- 3007420856
- 3012311599
- 3012263546
- 3009607734
- 3008820594
- 3013783488
- 2183646
- 3037341611
- 3015276780
- 3011420269
- 2032112
- 3013545943
- 3015134004
- 3012238587
- 9680215
- 3021343210
- 9681377
Source Documents#
Other 510(k) Records For Product Code DQA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260490 | Ninenovo Blood Oxygen Ring (BORMB-01-6,BORMB-01-7,BORMB-01-8,BORMB-01-9,BORMB-01-10,BORMB-01-11,BORMB-01-12,BORMB-01-13,BORMB-01-14) | Shenzhen Ninenovo Technology Limited | 2026-10-02 |
| 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 |
Legacy Summary#
summary
FDA Review#
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