Stabilet Infant Radiant Warmer Model 2000C
FDA 510(k) K913945 · Hill-Rom, Inc.
510(k) numberK913945
Submission
- Device name
- Stabilet Infant Radiant Warmer Model 2000C
- Applicant
- Hill-Rom, Inc.
Batesville, TN, US - Received
- September 4, 1991
- Decision date
- February 12, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 Stabilet Infant Radiant Warmer Model 2000C cleared by the FDA?
Stabilet Infant Radiant Warmer Model 2000C (K913945) received a 510(k) decision of Substantially Equivalent on February 12, 1992, 161 days after the submission was received.
What is the product code of K913945?
The FDA product code is FMT – Warmer, Infant Radiant, a Class II (moderate risk) device regulated under 21 CFR 880.5130.