Amsco Warming Cabinet
FDA 510(k) K111870 · STERIS Corporation
510(k) numberK111870
Submission
- Device name
- Amsco Warming Cabinet
- Applicant
- STERIS Corporation
Mentor, OH, US - Received
- July 1, 2011
- Decision date
- July 29, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LGZ – Warmer, Thermal, Infusion Fluid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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Questions and answers
When was Amsco Warming Cabinet cleared by the FDA?
Amsco Warming Cabinet (K111870) received a 510(k) decision of Substantially Equivalent on July 29, 2011, 28 days after the submission was received.
What is the product code of K111870?
The FDA product code is LGZ – Warmer, Thermal, Infusion Fluid, a Class II (moderate risk) device regulated under 21 CFR 880.5725.