Data / Medical devices / Ireland / Oxygen Research Institute Limited
Oxygen Research Institute Limited: FDA-registered device maker in Galway Galway(County), Ireland, 1 510(k) clearance
Oxygen Research Institute Limited is registered with the FDA (registration 3026199641) in Galway Galway(County), Ireland. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 10, 2008. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3026199641
- Address
- Loughwell Moycullen, Galway Galway(County), Ireland, H91 H4C1
- Owner or operator
- Oxygen Research Institute Limited (10087852)
- Roles
- Exporter to the US
- First device listed
- April 27, 2023
- Registered through
- 2026
- Brand names listed
- 3H Corporation, Contec Medical Systems Co. Ltd., JIANGSU YIZHENG CAREPRO MEDICAL INSTRUMENTS CO., LTD, JIANGSU YIZHENG CAREPRO MEDICAL INSTRUMENTS CO., LTD., Myotape, Nose Strip, waist support: SGKB009, Back Support
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Band Or Belt, Pelvic Support | ISR | 1 | Exporter to the US | accessdata.fda.gov |
| Dilator, Nasal | LWF | 1 | Exporter to the US | accessdata.fda.gov |
| Oximeter | DQA | 2 | Exporter to the US | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 10, 2008 | K082641 | FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL | DQA | Substantially Equivalent | Contec Medical System Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Tape And Bandage, Adhesive
- All makers of Oximeter
- All makers of Dilator, Nasal
- All makers of Band Or Belt, Pelvic Support
Updated November 10, 2008. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.