Biocomfort Diagnostics GmbH & Co. KG
GermanyFDA applicant, unverified
- Devices
- 2
What Biocomfort Diagnostics GmbH & Co. KG makes
Biocomfort Diagnostics manufactures automated blood pressure meters, including the TENSO-COMFORT BPM 105 and BPM 205 models, designed for clinical and home use. The company also provides a software application, Health Manager version 1.1, for monitoring and recording blood pressure readings.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. Biocomfort Diagnostics GmbH & Co. KG is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Health Manager, Version 1.1 Ref K081499
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biocomfort Diagnostics GmbH & Co. KG have in the registry?
The registry currently lists 2 devices for Biocomfort Diagnostics GmbH & Co. KG. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biocomfort Diagnostics GmbH & Co. KG's devices?
Among its 2 most recently registered devices, Biocomfort Diagnostics GmbH & Co. KG has devices listed in FDA 510(k) (2 devices).
What risk classes do Biocomfort Diagnostics GmbH & Co. KG's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Biocomfort Diagnostics GmbH & Co. KG's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biocomfort Diagnostics GmbH & Co. KG in the registry?
The most recently registered devices listed for Biocomfort Diagnostics GmbH & Co. KG include TENSO-COMFORT BLOOD PRESSURE METER, MODELS BPM 105 AND BPM 205 and HEALTH MANAGER, VERSION 1.1.