DPZClass II
Oximeter, Ear
21 CFR 870.2710 / Cardiovascular
DPZ is the FDA product code for Oximeter, Ear, a class II device type, regulated under 21 CFR 870.2710. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and 12 recalls.
Classification record
- Product code
- DPZ
- Device name
- Oximeter, Ear
- Regulation
- 21 CFR 870.2710
- Device class
- Class II
- Review panel
- Cardiovascular
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 11
- Ingested recalls
- 12
Clearances, product code DPZ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1981 | 1 |
| 1985 | 2 |
| 1986 | 1 |
| 1992 | 1 |
| 1994 | 2 |
| 2001 | 2 |
| 2004 | 2 |
Applicants with the most clearances
Product code DPZ| Applicant | Clearances |
|---|---|
| GE Healthcare | 2 |
| Epic Medical Equipment Services, Inc. | 2 |
| Bio-Tek Instruments, Inc. | 1 |
| Draeger, Inc. | 1 |
| Elekon Industries U.S.A., Inc. | 1 |
| Fitness Quest, Inc. | 1 |
| Marquette Electronics, Inc. | 1 |
| Nellcor, Inc. | 1 |
| Vitalog Corp. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Abbott Medical
- Amphenol Cable and Interconnect Technologies Asia Pacific Ltd.
- Amphenol Medical Technologies (Dongguan) Co., Ltd.
- Baxter Healthcare - Tel Aviv
- Boyd Corporation GmbH
- Buffalo Office
- Burak Global IC ve Dis Tic Ltd Sti
- Cardimed Asia Medikal Sanayi ve Ticaret Ltd Sti
- CBR Enterprise Limited
- Change Healthcare Canada Company
- Datascope Corp.
- DSV Contract Logistics
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
