Data / Medical devices / United States / Ventec Life Systems, Inc.
Ventec Life Systems, Inc.: FDA-registered device maker in Woodinville, WA, United States, 1 510(k) clearance
Ventec Life Systems, Inc. is registered with the FDA (registration 3017520736) in Woodinville, WA, United States. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 7, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017520736
- Address
- 12350 NE Woodinville Drive Building D, Suite A, Woodinville, WA, United States, 98072
- Owner or operator
- REACT HEALTH (10054872)
- Roles
- Manufacturer
- First device listed
- May 7, 2017
- Registered through
- 2026
- Brand names listed
- VOCSN
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous, Ventilator, Home Use | NOU | 2 | Manufacturer | accessdata.fda.gov |
| Device, Positive Pressure Breathing, Intermittent | NHJ | 2 | Manufacturer | accessdata.fda.gov |
| Filter, Bacterial, Breathing-Circuit | CAH | 2 | Manufacturer | accessdata.fda.gov |
| Generator, Oxygen, Portable | CAW | 2 | Manufacturer | accessdata.fda.gov |
| Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | BZE | 2 | Manufacturer | accessdata.fda.gov |
| Pump, Portable, Aspiration (Manual Or Powered) | BTA | 2 | 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 |
|---|---|---|---|---|---|---|
| April 7, 2017 | K162877 | VOCSN Unified Respiratory System | CBK | Substantially Equivalent | Ventec Life Systems, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Continuous, Ventilator, Home Use
- All makers of Pump, Portable, Aspiration (Manual Or Powered)
- All makers of Ventilator, Continuous, Facility Use
- All makers of Device, Positive Pressure Breathing, Intermittent
- All makers of Filter, Bacterial, Breathing-Circuit
- All makers of Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Updated April 7, 2017. 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.