Versacor, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Versacor, Inc. makes
Versacor, Inc. manufactures the CUSTO PORT 24-H ECG Ambulatory Recorder, a device for continuous electrocardiographic monitoring over a 24-hour period, and the CUSTO VIT Pulmonary Function Analysis System, used to assess lung function through spirometry and other respiratory measurements.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Custo Port 24-H Ecg Ambulatory Recorder Ref K854115
Regimes: 510(k) Registry: 510(k)Custo Vit Pulmonary Function Analysis System Ref K854745
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Versacor, Inc. have in the registry?
The registry currently lists 2 devices for Versacor, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Versacor, Inc.'s devices?
Among its 2 most recently registered devices, Versacor, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Versacor, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Versacor, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Versacor, Inc. in the registry?
The most recently registered devices listed for Versacor, Inc. include CUSTO PORT 24-H ECG AMBULATORY RECORDER and CUSTO VIT PULMONARY FUNCTION ANALYSIS SYSTEM.