C-V Monitors Corp.
United StatesFDA 510(k) applicant, unverified
- Devices
- 5
What C-V Monitors Corp. makes
C-V Monitors Corp. manufactures electrocardiogram (ECG) monitor scopes, including models 9502 and 9503, which display cardiac waveforms. Their portfolio also includes a blood pressure measurement module for real-time vital sign integration, a writer module (GEMINI-3) for recording ECG tracings, and DCG preamplifier modules to enhance signal clarity. Additionally, they produce 50mm ECG writer models, such as the CVM 9529, for permanent paper-based recordings.
The company’s devices are classified under FDA’s Class I and Class II categories, with relevant products listed via the 510(k) pathway. These products are intended for use in clinical and hospital settings within the United States, where regulatory compliance is governed by the FDA’s medical device regulations.
Catalogue
Monitor Scopes, Models 9502, 9503 Ref K790004
510(k) 510(k)Blood Pressure Module Ref K780571
510(k) 510(k)Writer, Gemini-3 Ref K781867
510(k) 510(k)Dcg Preamplifier Module Ref K780572
510(k) 510(k)50mm Writer Model Cvm 9529 Ref K792099
510(k) 510(k)
Frequently asked questions
How many devices does C-V Monitors Corp. have in the registry?
The registry currently lists 5 devices for C-V Monitors Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list C-V Monitors Corp.'s devices?
Among its 5 most recently registered devices, C-V Monitors Corp. has devices listed in FDA 510(k) (5 devices).
What risk classes do C-V Monitors Corp.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for C-V Monitors Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from C-V Monitors Corp. in the registry?
The most recently registered devices listed for C-V Monitors Corp. include MONITOR SCOPES, MODELS 9502, 9503, BLOOD PRESSURE MODULE, WRITER, GEMINI-3 and DCG PREAMPLIFIER MODULE.