Data / Medical devices / Israel / Orsense Ltd
Orsense Ltd: FDA-registered device maker in Tel Aviv Yafo Central, Israel, 1 510(k) clearance
Orsense Ltd is registered with the FDA (registration 3007358963) in Tel Aviv Yafo Central, Israel. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 16, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007358963
- Address
- 6 Ha'Nechoshet Street, Tel Aviv Yafo Central, Israel, 6971070
- Owner or operator
- OrSense (10032332)
- Roles
- Manufacturer
- First device listed
- January 18, 2015
- Registered through
- 2026
- Brand names listed
- NBM-200
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Hemoglobin For Donor Testing | QGU | 2 | Manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Manufacturer | accessdata.fda.gov |
| Oximeter To Measure Hemoglobin | GLY | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| January 16, 2015 | K142209 | Pulse oximeter NBM-200 | DQA | Substantially Equivalent | Orsense, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated January 16, 2015. 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.