Healthdyne Technologies, Inc.
United StatesFDA applicant, unverified
- Devices
- 9
What Healthdyne Technologies, Inc. makes
Healthdyne Technologies, Inc. manufactures respiratory support devices, including multichannel recording systems for diagnostic monitoring, pressure support ventilators for patient breathing assistance, and oxygen concentrators for delivering concentrated oxygen. The company also produces continuous positive airway pressure (CPAP) systems, bilevel positive airway pressure (BiPAP) devices, and nasal interfaces for airway management. Liquid oxygen systems and portable oxygen delivery units are part of its portfolio, designed for both clinical and home-use settings.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) clearance registry. All products are based in the United States and comply with U.S. medical device authorization requirements.
Catalogue
Simon Multichannel Recording System, Model 5500 Ref K983572
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
7300 Nasal Cpap System Ref K943509
Regimes: 510(k) Registry: 510(k)Alice 4R System Ref K971867
Regimes: 510(k) Registry: 510(k)Model 1700 Tranquility Bilevel System Ref K970173
Regimes: 510(k) Registry: 510(k)Protege Liquid Oxygen System Ref K971545
Regimes: 510(k) Registry: 510(k)Model 7410 Voyager Ref K974879
Regimes: 510(k) Registry: 510(k)Nasal Interface Model 7910 Ref K974453
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Healthdyne Technologies, Inc. have in the registry?
The registry currently lists 9 devices for Healthdyne Technologies, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Healthdyne Technologies, Inc.'s devices?
Among its 9 most recently registered devices, Healthdyne Technologies, Inc. has devices listed in FDA 510(k) (9 devices).
What risk classes do Healthdyne Technologies, Inc.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Healthdyne Technologies, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Healthdyne Technologies, Inc. in the registry?
The most recently registered devices listed for Healthdyne Technologies, Inc. include SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500, MODEL 7700 QUANTUM PRESSURE SUPPORT VENTILATOR PSV, TWISTER OXYGEN CONCENTRATOR MODEL 600, TWISTER OXYGEN CONCENTRATOR W/OPI MODEL 605 and 7300 NASAL CPAP SYSTEM.