DPZ — Oximeter, Ear Class II
FDA product code DPZ covers "Oximeter, Ear", a Class II medical device regulated under 21 CFR 870.2710. Submissions are reviewed by the Cardiovascular panel. At least 11 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DPZ
- Device Class
- Class II
- Regulation Number
- 870.2710
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K042675 | elekon industries u.s.a | FLEXI-STAT SP02 EAR SENSOR | December 6, 2004 |
| K040831 | datex-ohmeda | DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500 | September 2, 2004 |
| K012333 | epic medical equipment services | FLEXI-SITE SP02 EAR SENSOR | October 17, 2001 |
| K010718 | epic medical equipment services | FLEXI-SITE SP02 EAR SENSOR | March 23, 2001 |
| K944760 | nellcor | DURA-Y OXYGEN TRANSDUCER, EAR CLIP | October 17, 1994 |
| K942752 | marquette electronics | MARQUETTE EAR PROBE SENSOR | September 2, 1994 |
| K914595 | fitness quest | PULSE RATE MONITOR | January 31, 1992 |
| K862426 | draeger medical | PULSE OXIMETER | September 11, 1986 |
| K845051 | vitalog | VITALOG PMS-8 | May 15, 1985 |
| K850494 | ohmeda medical | OHMEDA BIOX 3700 PULSE OXIMETER | March 28, 1985 |
| K810363 | bio-tek instruments | EAR OXIMETER | February 27, 1981 |