Summit Doppler Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 7
What Summit Doppler Systems, Inc. makes
Summit Doppler Systems, Inc. manufactures Doppler ultrasound devices, including portable and handheld models like the LIFEDOP Doppler and LIFEDOP Model 300ABI for vascular assessments. Their portfolio also includes transvaginal Doppler probes (ECHOHEART) for obstetric and gynecological applications, as well as ankle-brachial index (ABI) systems (VANTAGE ABI) for peripheral arterial disease evaluation. Additional products include specialized Doppler probes (STN) and vascular imaging systems (VISTA AVS) for arterial and venous studies.
The company’s devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. These products are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device regulations. Summit Doppler Systems, Inc. is headquartered in the United States.
Catalogue
Lifedop Doppler Ref K024197
Regimes: 510(k) Registry: 510(k)Lifedop Model, L350R Ref K090499
Regimes: 510(k) Registry: 510(k)Echoheart Transvaginal Doppler Probe Ref K060410
Regimes: 510(k) Registry: 510(k)Vantage Abi Ref K103693
Regimes: 510(k) Registry: 510(k)Stn Probe Ref K101816
Regimes: 510(k) Registry: 510(k)Lifedop Model 300ABI Ref K093393
Regimes: 510(k) Registry: 510(k)Vista Avs Ref K063600
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Summit Doppler Systems, Inc. have in the registry?
The registry currently lists 7 devices for Summit Doppler Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Summit Doppler Systems, Inc.'s devices?
Among its 7 most recently registered devices, Summit Doppler Systems, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do Summit Doppler Systems, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Summit Doppler Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Summit Doppler Systems, Inc. in the registry?
The most recently registered devices listed for Summit Doppler Systems, Inc. include LIFEDOP DOPPLER, LIFEDOP MODEL, L350R, ECHOHEART TRANSVAGINAL DOPPLER PROBE and VANTAGE ABI.