Healthdyne, Inc.
United StatesFDA applicant, unverified
- Devices
- 35
What Healthdyne, Inc. makes
Healthdyne, Inc. manufactures respiratory support devices, including portable and stationary ventilators for adults and infants, oxygen concentrators, and apnea/heart monitors. Their product line also covers pulse oximeters, nasal CPAP systems, and diagnostic tools like event recorders and flow spirometers for pulmonary function testing.
The company’s devices are classified under FDA’s Class I and Class II categories, with regulatory submissions recorded in the FDA’s 510(k) database. These products are intended for use in clinical and home settings, adhering to U.S. medical device regulations. Healthdyne, Inc. is based in the United States.
Catalogue
Search and filter all 35 devicesFrequently asked questions
How many devices does Healthdyne, Inc. have in the registry?
The registry currently lists 35 devices for Healthdyne, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Healthdyne, Inc.'s devices?
Among its 35 most recently registered devices, Healthdyne, Inc. has devices listed in FDA 510(k) (35 devices).
What risk classes do Healthdyne, Inc.'s devices fall under?
Among its 35 most recently registered devices, the classes recorded for Healthdyne, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Healthdyne, Inc. in the registry?
The most recently registered devices listed for Healthdyne, Inc. include HEALTHDYNE IMPLUSE VENTILATOR, OXYGEN CONCENTRATOR, MODEL BX-5000, HEALTHDYNE'S EVENT RECORDER SYSTEM and HEALTHDYNE RATE METER.