Cardiodyne, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Cardiodyne, Inc. makes
Cardiodyne, Inc. manufactures blood pressure monitoring devices, including portable recorders and clinical-grade monitors like the CardioCassette II and the Kinetorr/PC series. These products are designed for continuous or intermittent measurement of blood pressure in medical and research settings.
The company’s portfolio consists of Class II medical devices, regulated under the FDA’s 510(k) clearance process. These devices are listed in the FDA’s 510(k) database, reflecting their authorised status for commercial distribution in the United States.
Catalogue
Cardiocassette Ii Ref K772027
Regimes: 510(k) Registry: 510(k)Blood Pressure Recorder Ref K781932
Regimes: 510(k) Registry: 510(k)Cardiodyne Kinetorr/Pc Blood Pressure Monitors Ref K911871
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cardiodyne, Inc. have in the registry?
The registry currently lists 3 devices for Cardiodyne, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cardiodyne, Inc.'s devices?
Among its 3 most recently registered devices, Cardiodyne, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Cardiodyne, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Cardiodyne, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cardiodyne, Inc. in the registry?
The most recently registered devices listed for Cardiodyne, Inc. include CARDIOCASSETTE II, BLOOD PRESSURE RECORDER and CARDIODYNE KINETORR/PC BLOOD PRESSURE MONITORS.