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Sign in to claim this brandAutomedx, Inc.
US
Last updated May 23, 2026
What Automedx, Inc. makes
Automedx, Inc. manufactures transport electric ventilators, including the SAVe II+ and SAVE-SIMPLIFIED AUTOMATED VENTILATOR models (550X10, 600X10, 600X12), as well as the SAVe II and SAVe II BASIC. These devices are designed for portable ventilation support during patient transport.
The company’s ventilators are classified as Class II medical devices under FDA regulations and are listed via 510(k) and UDI pathways. The products are based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Automedx, Inc. manufacture?
Automedx, Inc. specializes in transport electric ventilators, which are portable devices used to provide ventilation support during patient transport. These devices are designed to ensure continuous respiratory assistance while moving patients between care settings, such as from a hospital room to an ambulance or between different hospital units.
Where is Automedx, Inc. based?
Automedx, Inc. is headquartered in the United States. The company’s focus on transport ventilators reflects its commitment to developing solutions tailored to the needs of mobile patient care environments within the US healthcare system.
Which regulatory registries or databases list Automedx, Inc.’s devices?
Automedx, Inc.’s devices are listed in the FDA’s 510(k) premarket notification pathway and the Unique Device Identifier (UDI) system. These registries ensure traceability and compliance tracking for Class II ventilators, which require demonstration of substantial equivalence to legally marketed predicates before commercialization.
How are Automedx, Inc.’s ventilators classified under FDA regulations?
Automedx, Inc.’s ventilators fall under Class II classification by the FDA. This classification is assigned based on the device’s risk level and intended use—transport ventilators are considered moderate-risk due to their critical role in patient care during transport, requiring special controls beyond general controls to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
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Catalogue (6)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SAVe II+ | M50016 | FDA UDI | Class II | Active |
| SAVe II+ | 70111H-US | FDA UDI | Class II | Active |
| SAVe II+ | 70110H-US | FDA UDI | Class II | Active |
| SAVe II+ | 70110H-EU | FDA UDI | Class II | Active |
| Save-Simplified Automated Ventilator, Models: 550x10, 600x10 And 600x12 | K071221 | FDA 510(k) | Class II | Active |
| Save Ii, Save Ii Basic | K131877 | FDA 510(k) | Class II | Active |
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