Panda iRes Warmer, Giraffe Warmer
FDA 510(k) K201628 · GE Healthcare
510(k) numberK201628
Submission
- Device name
- Panda iRes Warmer, Giraffe Warmer
- Applicant
- GE Healthcare
Wauwatosa, WI, US - Received
- June 16, 2020
- Decision date
- February 12, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMT – Warmer, Infant Radiant
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5130
- Specialty
- General Hospital
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Questions and answers
When was Panda iRes Warmer, Giraffe Warmer cleared by the FDA?
Panda iRes Warmer, Giraffe Warmer (K201628) received a 510(k) decision of Substantially Equivalent on February 12, 2021, 241 days after the submission was received.
What is the product code of K201628?
The FDA product code is FMT – Warmer, Infant Radiant, a Class II (moderate risk) device regulated under 21 CFR 880.5130.