Babyroo TN300
FDA 510(k) K230278 · Draeger Medical Systems, Inc.
510(k) numberK230278
Submission
- Device name
- Babyroo TN300
- Applicant
- Draeger Medical Systems, Inc.
Telford, PA, US - Received
- February 1, 2023
- Decision date
- May 30, 2023
- 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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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243606 | Babyroo TN300FMT · Traditional | Draeger Medical Systems, Inc. | 01/17/2025SE |
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| K173516 | NuBorne Infant WarmerFMT · Abbreviated | International Biomedical | 08/17/2018SE |
| K123309 | Giraffe and Panda WarmersFMT · Traditional | Ohmeda Medical | 02/05/2013SE |
| K120642 | Resuscitaire with AutobreathFMT · Traditional | Draeger Medical Systems, Inc. | 11/02/2012SE |
| K122267 | Giraffe and Panda WarmersFMT · Special | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | 10/02/2012SE |
| K121625 | Lullaby TM WarmerFMT · Traditional | Wipro GE Healthcare Private, Ltd. | 09/14/2012SE |
More from Wipro GE Healthcare Private, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K260579 | Infinity® Acute Care System (IACS) VG8.1MHX · Traditional | 08/20/2026SE |
| K243606 | Babyroo TN300FMT · Traditional | 01/17/2025SE |
| K240312 | Infinity CentralStation WideMHX · Traditional | 08/01/2024SE |
| K233834 | Infinity Gateway SuiteMSX · Traditional | 07/12/2024SE |
| K231477 | Infinity CentralStation Wide, Infinity M300, Infinity M300+MHX · Traditional | 10/17/2023SE |
| K203579 | Infinity Gateway SuiteMSX · Traditional | 06/07/2022SE |
| K203088 | Infinity Acute Care System (IACS) Monitoring SystemMHX · Traditional | 02/01/2022SE |
| K201764 | Infinity Acute Care System (IACS) Monitoring SolutionMHX · Traditional | 12/09/2021SE |
| K200859 | Infinity M300MHX · Traditional | 08/28/2020SE |
| K182977 | Isolette 8000 PlusFMZ · Special | 11/21/2018SE |
Questions and answers
When was Babyroo TN300 cleared by the FDA?
Babyroo TN300 (K230278) received a 510(k) decision of Substantially Equivalent on May 30, 2023, 118 days after the submission was received.
What is the product code of K230278?
The FDA product code is FMT – Warmer, Infant Radiant, a Class II (moderate risk) device regulated under 21 CFR 880.5130.