Medizin Systeme Boblingen GmbH
GermanyFDA applicant, unverified
- Devices
- 1
What Medizin Systeme Boblingen GmbH makes
Medizin Systeme Boblingen GmbH manufactures the PageWriter TC35 Cardiograph, a device designed for electrocardiogram (ECG) recording and analysis to capture and display heart activity.
The PageWriter TC35 Cardiograph is classified as a Class II medical device and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
PageWriter TC35 Cardiograph Ref K221141
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Medizin Systeme Boblingen GmbH have in the registry?
The registry currently lists 1 device for Medizin Systeme Boblingen GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medizin Systeme Boblingen GmbH's devices?
Among its 1 most recently registered device, Medizin Systeme Boblingen GmbH has devices listed in FDA 510(k) (1 device).
What risk classes do Medizin Systeme Boblingen GmbH's devices fall under?
Among its 1 most recently registered device, the classes recorded for Medizin Systeme Boblingen GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Medizin Systeme Boblingen GmbH in the registry?
The most recently registered devices listed for Medizin Systeme Boblingen GmbH include PageWriter TC35 Cardiograph.