Dura-Y Oxygen Transducer, Ear Clip
FDA 510(k) K944760 · Nellcor, Inc.
510(k) numberK944760
Submission
- Device name
- Dura-Y Oxygen Transducer, Ear Clip
- Applicant
- Nellcor, Inc.
Chula Vista, CA, US - Received
- September 27, 1994
- Decision date
- October 17, 1994
- 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 |
| K040831 | Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500DPZ · Traditional | Datex-Ohmeda, Inc. | 09/02/2004SE |
| 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 |
| 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 |
More from Bio-Tek Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K953472 | Nellcor Symphony N-3100 Blood Pressure MonitorDXN · Traditional | 10/20/1995SE |
| K952316 | Nellcor Symphony N-3000 Pulse OximeterDQA · Traditional | 08/17/1995SE |
| K952222 | Nellcor N-20PA Portable Pulse OximeterDQA · Traditional | 08/15/1995SE |
| K942347 | Nellcor Symphony Pulse Oximeter Model N-3000DQA · Traditional | 05/12/1995SE |
| K945947 | Nellcor Symphony(Tm) N-3100 Blood Pressure Monitor and Connected to the Nellcor…DXN · Traditional | 03/08/1995SE |
| K944400 | Pedi-CapCCK · Traditional | 09/27/1994SE |
| K915494 | Nellcor Stat-Cap Airway CO2 Indicator, Model N-60CCK · Traditional | 08/06/1993SE |
| K915699 | Nellcor Portable Pulse Oximeter Model N-20DQA · Traditional | 05/27/1993SE |
| K913695 | Nellcor(R) N-180 Pulse OximeterDQA · Traditional | 11/13/1991SE |
| K904039 | Reflectance Sensor (RS-10)DQA · Traditional | 12/27/1990SE |
Questions and answers
When was Dura-Y Oxygen Transducer, Ear Clip cleared by the FDA?
Dura-Y Oxygen Transducer, Ear Clip (K944760) received a 510(k) decision of Substantially Equivalent on October 17, 1994, 20 days after the submission was received.
What is the product code of K944760?
The FDA product code is DPZ – Oximeter, Ear, a Class II (moderate risk) device regulated under 21 CFR 870.2710.