Panels › Cardiovascular › Product code DPZ · Class 2
Oximeter, Ear
Regulation 870.2710
0510(k)s in 12 months (11 all time)
0recalls in 12 months (12 all time)
12recalls that name a 510(k)
Top companies in DPZ
| Company | 510(k)s | Recalls |
|---|---|---|
| GE Healthcare Finland Oy | 0 | 9 |
| Datex-Ohmeda, Inc. | 1 | 1 |
| Epic Medical Equipment Services, Inc. | 2 | 0 |
| GE Healthcare, LLC | 0 | 2 |
| Bio-Tek Instruments, Inc. | 1 | 0 |
| Draeger Medical, Inc. | 1 | 0 |
| Elekon Industries U.S.A., Inc. | 1 | 0 |
| Fitness Quest, Inc. | 1 | 0 |
| Marquette Electronics, Inc. | 1 | 0 |
| Nellcor, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 7, 2023 | GE Healthcare Finland Oy TruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; Oximeter Open, Classified |
DPZ | K021955 |
| Jul 7, 2023 | GE Healthcare Finland Oy TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-N; Oximeter Open, Classified |
DPZ | K021955 |
| Jul 7, 2023 | GE Healthcare Finland Oy TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, physiological, patient(with arrhythmia detection or alarms) Open, Classified |
DPZ | K040831 |
| Jul 7, 2023 | GE Healthcare Finland Oy TruSignal Integrated Ear Sensor with GE Connector REF TS-E2-GE; Oximeter, Ear Open, Classified |
DPZ | K040831 |
| Jul 7, 2023 | GE Healthcare Finland Oy TruSignal Ear Sensor, REF TS-E-D; Oximeter Open, Classified |
DPZ | K093881 |
| Jul 7, 2023 | GE Healthcare Finland Oy TruSignal Wrap Sensor, REF TS-W-D; Oximeter Open, Classified |
DPZ | K093881 |
| Jul 7, 2023 | GE Healthcare Finland Oy TruSignal Sensitive Skin Sensor, REF TS-SE-3; Oximeter Open, Classified |
DPZ | K093881 |
| Jul 7, 2023 | GE Healthcare Finland Oy TruSignal AllFit Sensor:
a) REF TS-AF-10, 10 pcs;
B) REF AF-25, 25 pcs; Oximeter Open, Classified |
DPZ | K093881 |
| Jul 7, 2023 | GE Healthcare Finland Oy TruSignal Adult/Pediatric Sensor; Oximeter, Ear:
a) REF TS-AP-10, 10 pcs;
b) REF TS-AP-25, 25 pcs Open, Classified |
DPZ | K040831 |
| Sep 14, 2011 | GE Healthcare, LLC DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500 (GE Healthcare) Terminated |
DPZ | K040831 |
| Jun 22, 2010 | Ge Healthcare, Llc DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500 Terminated |
DPZ | K040831 |
| Mar 5, 2003 | Datex-Ohmeda Datex-Ohmeda Cardiocap/5 Anesthesia Monitor with N-XOSAT SpO2 measurement option Terminated |
DPZ | K012837 |
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