Datamed, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Datamed, Inc. makes
Datamed, Inc. manufactures respiratory diagnostic devices, including the SpiroLoop and Spiro-Loop for pulmonary function testing, as well as the DataMed Model 401A Transreceiver for data transmission in medical monitoring applications.
The company’s products are regulated under FDA’s Class I and Class II classifications, with relevant devices listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Spiroloop Ref K841858
Regimes: 510(k) Registry: 510(k)Sprio-Loop Ref K811419
Regimes: 510(k) Registry: 510(k)Datamed Model 401A Transreciever Ref K904966
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Datamed, Inc. have in the registry?
The registry currently lists 3 devices for Datamed, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Datamed, Inc.'s devices?
Among its 3 most recently registered devices, Datamed, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Datamed, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Datamed, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Datamed, Inc. in the registry?
The most recently registered devices listed for Datamed, Inc. include SPIROLOOP, SPRIO-LOOP and DATAMED MODEL 401A TRANSRECIEVER.