DPZ · Oximeter, Ear
Cardiovascular · 21 CFR 870.2710 · Class 2
Overview
| Product Code | DPZ |
|---|---|
| Device Name | Oximeter, Ear |
| Regulation | 21 CFR 870.2710 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
An ear oximeter is an extravascular device used to transmit light at a known wavelength(s) through blood in the ear. The amount of reflected or scattered light as indicated by this device is used to measure the blood oxygen saturation.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K042675 | FLEXI-STAT SP02 EAR SENSOR | Elekon Industries U.S.A., Inc. | Dec 6, 2004 | SESE |
| K040831 | DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500 | Datex-Ohmeda, Inc. | Sep 2, 2004 | SESE |
| K012333 | FLEXI-SITE SP02 EAR SENSOR | Epic Medical Equipment Services, Inc. | Oct 17, 2001 | SESE |
| K010718 | FLEXI-SITE SP02 EAR SENSOR | Epic Medical Equipment Services, Inc. | Mar 23, 2001 | SESE |
| K944760 | DURA-Y OXYGEN TRANSDUCER, EAR CLIP | Nellcor, Inc. | Oct 17, 1994 | SESE |
| K942752 | MARQUETTE EAR PROBE SENSOR | Marquette Electronics, Inc. | Sep 2, 1994 | SESE |
| K914595 | PULSE RATE MONITOR | Fitness Quest, Inc. | Jan 31, 1992 | SESE |
| K862426 | PULSE OXIMETER | Draeger Medical, Inc. | Sep 11, 1986 | SESE |
| K845051 | VITALOG PMS-8 | Vitalog Corp. | May 15, 1985 | SESE |
| K850494 | OHMEDA BIOX 3700 PULSE OXIMETER | Ohmeda Medical | Mar 28, 1985 | SESE |
| K810363 | EAR OXIMETER | Bio-Tek Instruments, Inc. | Feb 27, 1981 | SESE |
Top Applicants
- Epic Medical Equipment Services, Inc. — 2 clearances
- Bio-Tek Instruments, Inc. — 1 clearance
- Datex-Ohmeda, Inc. — 1 clearance
- Draeger Medical, Inc. — 1 clearance
- Elekon Industries U.S.A., Inc. — 1 clearance
