Data / Medical devices / Israel / Inovytec Medical Solutions Ltd.
Inovytec Medical Solutions Ltd.: FDA-registered device maker in Raanana Central, Israel, 1 510(k) clearance
Inovytec Medical Solutions Ltd. is registered with the FDA (registration 3011213495) in Raanana Central, Israel. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 29, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011213495
- Address
- 5 HaTidhar St., Industrial Zone, Raanana Central, Israel, 4366507
- Owner or operator
- Inovytec Medical Solutions Ltd. (10047253)
- Roles
- Manufacturer
- First device listed
- July 28, 2014
- Registered through
- 2026
- Brand names listed
- Lubo Airway Collar, Mini Lubo Airway Collar, VWSP-100, VWSP-100MR, VWSP-1450F, VWSP-1550F, VWSP-304, VWSP-370 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Orthosis, Cervical | IQK | 1 | Manufacturer | accessdata.fda.gov |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | 1 | Manufacturer | accessdata.fda.gov |
| Ventilator, Continuous, Facility Use | CBK | 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 29, 2021 | K202970 | Ventway Sparrow | CBK | Substantially Equivalent | Inovytech Medical Solutions , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Orthosis, Cervical
- All makers of Set, Tubing And Support, Ventilator (W Harness)
- All makers of Ventilator, Continuous, Facility Use
Updated January 29, 2021. 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.