Sie-Med, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Sie-Med, Inc. makes
Sie-Med, Inc. manufactures thermographic imaging systems, including the REGUTHERM 952 THERMOGRAPHIC SYSTEM for medical thermal imaging, and the ULTRATHERM (908) device, which appears to be a related thermal monitoring or diagnostic tool.
These products are regulated under FDA Class I and Class II classifications, with authorisation records maintained in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
Regutherm 952 Thermographic System Ref K003130
Regimes: 510(k) Registry: 510(k)Ultratherm (908) Ref K964083
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sie-Med, Inc. have in the registry?
The registry currently lists 2 devices for Sie-Med, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sie-Med, Inc.'s devices?
Among its 2 most recently registered devices, Sie-Med, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Sie-Med, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Sie-Med, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sie-Med, Inc. in the registry?
The most recently registered devices listed for Sie-Med, Inc. include REGUTHERM 952 THERMOGRAPHIC SYSTEM and ULTRATHERM (908).