Erecords Enterprises
CanadaFDA 510(k) applicant, unverified
- Devices
- 1
What Erecords Enterprises makes
Erecords Enterprises manufactures the ESTATION electronic stethoscope (Model DR200), a digital diagnostic tool designed for auscultation in clinical settings. The device converts acoustic signals into electronic output for enhanced sound amplification and recording.
The ESTATION electronic stethoscope (Model DR200) is classified as a Class II medical device in the US and is listed under FDA’s 510(k) clearance process. The company is based in the United States.
Catalogue
Estation Electronic Stethoscope, Model DR200 Ref K001788
510(k) 510(k)
Frequently asked questions
How many devices does Erecords Enterprises have in the registry?
The registry currently lists 1 device for Erecords Enterprises. Devices recorded under merged duplicate company entries are counted once.
Which registries list Erecords Enterprises's devices?
Among its 1 most recently registered device, Erecords Enterprises has devices listed in FDA 510(k) (1 device).
What risk classes do Erecords Enterprises's devices fall under?
Among its 1 most recently registered device, the classes recorded for Erecords Enterprises's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Erecords Enterprises in the registry?
The most recently registered devices listed for Erecords Enterprises include ESTATION ELECTRONIC STETHOSCOPE, MODEL DR200.