Lullaby TM Warmer
FDA 510(k) K121625 · Wipro GE Healthcare Private, Ltd.
510(k) numberK121625
Submission
- Device name
- Lullaby TM Warmer
- Applicant
- Wipro GE Healthcare Private, Ltd.
Laurel, MD, US - Received
- June 1, 2012
- Decision date
- September 14, 2012
- 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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| K243606 | Babyroo TN300FMT · Traditional | Draeger Medical Systems, Inc. | 01/17/2025SE |
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| K213551 | Giraffe Omnibed Carestation CS1FMT · Traditional | Datex Ohmeda, Inc. | 03/02/2022SE |
| K201628 | Panda iRes Warmer, Giraffe WarmerFMT · Traditional | GE Healthcare | 02/12/2021SE |
| K200319 | HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface…FMT · Traditional | Deroyal Industries, Inc. | 04/02/2020SE |
| K191425 | Hydro-Temp Neonatal Skin Temperature Probe CoverFMT · Traditional | Deroyal Industries, Inc. | 01/21/2020SE |
| 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 |
More from Ohmeda Medical, A Division of Datex-Ohmeda, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K123681 | 1.5T 4CH Large Flex Coil, 1.5 4CH Small Flex CoilMOS · Traditional | 02/22/2013SE |
| K120168 | Lullaby LED Phottherapy SystemLBI · Traditional | 05/02/2012SE |
| K110556 | Mini Telemetry SystemHGM · Traditional | 07/19/2011SE |
| K102104 | GE Vivid P3 Diagnostic Ultrasound Imaging SystemIYN · Special | 10/01/2010SE |
Questions and answers
When was Lullaby TM Warmer cleared by the FDA?
Lullaby TM Warmer (K121625) received a 510(k) decision of Substantially Equivalent on September 14, 2012, 105 days after the submission was received.
What is the product code of K121625?
The FDA product code is FMT – Warmer, Infant Radiant, a Class II (moderate risk) device regulated under 21 CFR 880.5130.