Epson America, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 3
What Epson America, Inc. makes
Epson America, Inc. manufactures digital and modified digital clinical thermometers, including oral models like the Survalent II, designed for medical and healthcare settings. These devices provide precise temperature readings for patient monitoring and diagnostic purposes.
The company’s thermometers are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearance records. These products are listed in the FDA’s 510(k) database and are intended for use in the United States.
Catalogue
Modified Digital Clinical Thermometer Ref K880759
510(k) 510(k)Survalent Ii Oral Thermometer Ref K923289
510(k) 510(k)Digital Thermometer Ref K853824
510(k) 510(k)
Frequently asked questions
How many devices does Epson America, Inc. have in the registry?
The registry currently lists 3 devices for Epson America, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Epson America, Inc.'s devices?
Among its 3 most recently registered devices, Epson America, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Epson America, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Epson America, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Epson America, Inc. in the registry?
The most recently registered devices listed for Epson America, Inc. include MODIFIED DIGITAL CLINICAL THERMOMETER, SURVALENT II ORAL THERMOMETER and DIGITAL THERMOMETER.