Sensor Medics Corp.
United StatesFDA applicant, unverified
- Devices
- 27
What Sensor Medics Corp. makes
Sensor Medics Corp. manufactures respiratory care devices, including infant flow non-invasive continuous positive airway pressure (NCPAP) masks, spirometry systems, and pulmonary function testing equipment. Their portfolio also covers nasal CPAP systems, nasal masks, and modifications to oxygen delivery devices such as the OxyShuttle II and HiOx. The company produces systems for both clinical and home use, such as the Pegasus Nasal CPAP System and the Lyra Nasal Mask, alongside specialized spirometers and pulmonary function laboratories.
The company’s devices are classified under FDA Class II, requiring premarket notification (510(k)) or premarket approval (PMA) authorization. These products are listed in the FDA’s regulatory databases, and the manufacturer is based in the United States. Compliance with FDA requirements ensures their devices meet specified performance and safety standards for respiratory therapy applications.
Catalogue
Search and filter all 27 devicesFrequently asked questions
How many devices does Sensor Medics Corp. have in the registry?
The registry currently lists 27 devices for Sensor Medics Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sensor Medics Corp.'s devices?
Among its 27 most recently registered devices, Sensor Medics Corp. has devices listed in FDA 510(k) (26 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Sensor Medics Corp.'s devices fall under?
Among its 27 most recently registered devices, the classes recorded for Sensor Medics Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sensor Medics Corp. in the registry?
The most recently registered devices listed for Sensor Medics Corp. include INFANT FLOW NCPAP MASKS, SENSORMEDICS MODEL 2130 SPIEOMETRY SYSTEM, SENSORMEDICS MODEL 922 SPIROMETER and OXYSHUTTLE II, MODIFICATION.