Heart Sounds, Inc.
CanadaFDA applicant, unverified
- Devices
- 1
What Heart Sounds, Inc. makes
Heart Sounds, Inc. manufactures the ANALYST (Model DSP 300), a device designed for analyzing and interpreting cardiac sounds, likely for diagnostic purposes in clinical settings.
The company’s portfolio is regulated under FDA Class II devices and requires 510(k) clearance. The product is listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Analyst, Model Dsp 300 Ref K950760
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Heart Sounds, Inc. have in the registry?
The registry currently lists 1 device for Heart Sounds, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Heart Sounds, Inc.'s devices?
Among its 1 most recently registered device, Heart Sounds, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Heart Sounds, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Heart Sounds, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Heart Sounds, Inc. in the registry?
The most recently registered devices listed for Heart Sounds, Inc. include ANALYST, MODEL DSP 300.