The Merlin Corp.
United StatesFDA applicant, unverified
- Devices
- 2
What The Merlin Corp. makes
The Merlin Corp. manufactures the MISTASSIST Breathing Exerciser, a device designed for respiratory training and support, and the MISTASSIST, a related product for inhalation therapy or airway clearance.
The company’s portfolio includes Class I and Class II devices, all of which are listed under the FDA’s 510(k) pathway. These products are regulated under US medical device laws and are based in the United States.
Catalogue
Mistassist Breathing Exerciser Ref K953055
Regimes: 510(k) Registry: 510(k)Mistassist Ref K942789
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does The Merlin Corp. have in the registry?
The registry currently lists 2 devices for The Merlin Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list The Merlin Corp.'s devices?
Among its 2 most recently registered devices, The Merlin Corp. has devices listed in FDA 510(k) (2 devices).
What risk classes do The Merlin Corp.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for The Merlin Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from The Merlin Corp. in the registry?
The most recently registered devices listed for The Merlin Corp. include MISTASSIST BREATHING EXERCISER and MISTASSIST.