Koven and Assoc., Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 8
What Koven and Assoc., Inc. makes
Koven and Assoc., Inc. manufactures ambulatory blood pressure monitoring systems, bidirectional blood flow meters, Doppler ultrasound blood flow detectors, and vascular testing systems. Their portfolio includes handheld and portable devices for measuring blood flow velocity, directional flow analysis, and continuous ambulatory blood pressure tracking.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) clearance registry. All products are based in the United States.
Catalogue
- 510(k) 510(k)
Multidop Model Hd-2020 Bi-Directional Blood Flow Ref K922669
510(k) 510(k)Model Hd-207 Bidirectional Velocity Meter Ref K912409
510(k) 510(k)Hd-2200 Pneumo-Dop Vascular Testing System Ref K894892
510(k) 510(k)Mini Doppler Ii Ultrasound Blood Flow Detector Ref K915550
510(k) 510(k)Smartdop 20 Bi-Directional Blood Flow Detector Ref K920333
510(k) 510(k)Dvm-4200 Blood Flowmeter Ref K892707
510(k) 510(k)Es-1000SP Ii Smart Dop Ref K903026
510(k) 510(k)
Frequently asked questions
How many devices does Koven and Assoc., Inc. have in the registry?
The registry currently lists 8 devices for Koven and Assoc., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Koven and Assoc., Inc.'s devices?
Among its 8 most recently registered devices, Koven and Assoc., Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Koven and Assoc., Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Koven and Assoc., Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Koven and Assoc., Inc. in the registry?
The most recently registered devices listed for Koven and Assoc., Inc. include DS-240 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM, MULTIDOP MODEL HD-2020 BI-DIRECTIONAL BLOOD FLOW, MODEL HD-207 BIDIRECTIONAL VELOCITY METER and HD-2200 PNEUMO-DOP VASCULAR TESTING SYSTEM.