Apieron, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Apieron, Inc. makes
Apieron, Inc. manufactures systems for measuring exhaled nitric oxide (ENO), including the APIERON INSIGHT ENO System and the APIERON INSIGHT Exhaled Nitric Oxide (ENO) System. These devices are designed to analyze ENO levels in patients to support respiratory health assessments.
The company’s products are classified as Class II medical devices in the US and are listed under the FDA’s 510(k) pathway. Apieron, Inc. is based in the United States.
Catalogue
Apieron Insight Eno System Ref K083617
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Apieron, Inc. have in the registry?
The registry currently lists 2 devices for Apieron, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Apieron, Inc.'s devices?
Among its 2 most recently registered devices, Apieron, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Apieron, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Apieron, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Apieron, Inc. in the registry?
The most recently registered devices listed for Apieron, Inc. include APIERON INSIGHT ENO SYSTEM and APIERON INSIGHT EXHALED NITRIC OXIDE (ENO) SYSTEM.