Incuwarmer
FDA 510(k) K971366 · Hill-Rom, Inc.
510(k) numberK971366
Submission
- Device name
- Incuwarmer
- Applicant
- Hill-Rom, Inc.
Batesville, IN, US - Received
- April 14, 1997
- Decision date
- January 5, 1998
- 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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| K013709 | Hill-Rom Primaview Monitor SystemFET · Traditional | 11/16/2001SE |
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| K972111 | Rumors Dynamic Air Therapy UnitIKZ · Traditional | 02/02/1998SE |
Questions and answers
When was Incuwarmer cleared by the FDA?
Incuwarmer (K971366) received a 510(k) decision of Substantially Equivalent on January 5, 1998, 266 days after the submission was received.
What is the product code of K971366?
The FDA product code is FMT – Warmer, Infant Radiant, a Class II (moderate risk) device regulated under 21 CFR 880.5130.