Mauna Loa Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Mauna Loa Medical, Inc. makes
Mauna Loa Medical, Inc. manufactures disposable breathing circuits designed for heated, humidified gas delivery in respiratory therapy, including the Enhanced Heated Breathing Circuit. The company also produces the LAVABED System and Chamber, a reusable patient care chamber with integrated temperature control for cleaning and disinfection processes.
The company’s products are regulated under FDA’s Class I and Class II classifications, with relevant devices listed via the 510(k) pathway. These devices are intended for use in the United States, where Mauna Loa Medical, Inc. is based.
Catalogue
Mauna Loa Enhanced Heated Breathing Circuit Ref K904538
Regimes: 510(k) Registry: 510(k)Lavabed System & Chamber, Lavapak Temp. Control Ref K870173
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Mauna Loa Medical, Inc. have in the registry?
The registry currently lists 2 devices for Mauna Loa Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mauna Loa Medical, Inc.'s devices?
Among its 2 most recently registered devices, Mauna Loa Medical, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Mauna Loa Medical, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Mauna Loa Medical, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Mauna Loa Medical, Inc. in the registry?
The most recently registered devices listed for Mauna Loa Medical, Inc. include MAUNA LOA ENHANCED HEATED BREATHING CIRCUIT and LAVABED SYSTEM & CHAMBER, LAVAPAK TEMP. CONTROL.