Data / Medical devices / Israel / Dormotech Medical Ltd.
Dormotech Medical Ltd.: FDA-registered device maker in Afula Northern, Israel, 2 510(k) clearances
Dormotech Medical Ltd. is registered with the FDA (registration 3038185755) in Afula Northern, Israel. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 8, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3038185755
- Address
- Yitzhak rabin, Afula Northern, Israel, 121
- Owner or operator
- Dormotech Medical Ltd. (10093114)
- Roles
- Specification developer
- First device listed
- April 1, 2025
- Registered through
- 2026
- Brand names listed
- DormoTech NLab, DormoVision, Vlab
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Amplifier, Physiological Signal | GWL | 2 | Specification developer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Specification developer | accessdata.fda.gov |
| Ventilatory Effort Recorder | MNR | 2 | Specification developer | 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 8, 2025 | K242290 | DormoTech NLab | MNR | Substantially Equivalent | Dormotech Medical, Ltd. | accessdata.fda.gov |
| October 11, 2023 | K230148 | Vlab | GWL | Substantially Equivalent | Dormotech Medical, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Oximeter
- All makers of Amplifier, Physiological Signal
- All makers of Ventilatory Effort Recorder
Updated January 8, 2025. 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.