Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500
FDA 510(k) K040831 · Datex-Ohmeda, Inc.
510(k) numberK040831
Submission
- Device name
- Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500
- Applicant
- Datex-Ohmeda, Inc.
Louisville, CO, US - Received
- March 31, 2004
- Decision date
- September 2, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DPZ – Oximeter, Ear
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2710
- Specialty
- Cardiovascular
Other 510(k)s with product code DPZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K042675 | Flexi-Stat SP02 Ear SensorDPZ · Traditional | Elekon Industries U.S.A., Inc. | 12/06/2004SE |
| K012333 | Flexi-Site SP02 Ear SensorDPZ · Special | Epic Medical Equipment Services, Inc. | 10/17/2001SE |
| K010718 | Flexi-Site SP02 Ear SensorDPZ · Special | Epic Medical Equipment Services, Inc. | 03/23/2001SE |
| K944760 | Dura-Y Oxygen Transducer, Ear ClipDPZ · Traditional | Nellcor, Inc. | 10/17/1994SE |
| K942752 | Marquette Ear Probe SensorDPZ · Traditional | Marquette Electronics, Inc. | 09/02/1994SE |
| K914595 | Pulse Rate MonitorDPZ · Traditional | Fitness Quest, Inc. | 01/31/1992SE |
| K862426 | Pulse OximeterDPZ · Traditional | Draeger Medical, Inc. | 09/11/1986SE |
| K845051 | Vitalog PMS-8DPZ · Traditional | Vitalog Corp. | 05/15/1985SE |
| K850494 | Ohmeda Biox 3700 Pulse OximeterDPZ · Traditional | Ohmeda Medical | 03/28/1985SE |
| K810363 | Ear OximeterDPZ · Traditional | Bio-Tek Instruments, Inc. | 02/27/1981SE |
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| K213553 | Giraffe Incubator Carestation CS1FMZ · Traditional | 03/02/2022SE |
| K213551 | Giraffe Omnibed Carestation CS1FMT · Traditional | 03/02/2022SE |
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| K172702 | Tec 820, Tec 850CAD · Traditional | 01/04/2018SE |
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Questions and answers
When was Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500 cleared by the FDA?
Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500 (K040831) received a 510(k) decision of Substantially Equivalent on September 2, 2004, 155 days after the submission was received.
What is the product code of K040831?
The FDA product code is DPZ – Oximeter, Ear, a Class II (moderate risk) device regulated under 21 CFR 870.2710.