Neo-Servo I
FDA 510(k) K102710 · Atom Medical Corporation
510(k) numberK102710
Submission
- Device name
- Neo-Servo I
- Applicant
- Atom Medical Corporation
Bonita Springs, FL, US - Received
- September 20, 2010
- Decision date
- December 22, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMZ – Incubator, Neonatal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5400
- Specialty
- General Hospital
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| K251619 | Babyleo TN500FMZ · Traditional | Drägerwerk AG & Co. KGaA | 02/13/2026SE |
| K251663 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)FMZ · Traditional | Datex-Ohmeda, Inc. | 10/22/2025SE |
| K243437 | mOm Essential Incubator (ME1)FMZ · Traditional | Mom Incubators Limited | 08/14/2025SE |
| K213553 | Giraffe Incubator Carestation CS1FMZ · Traditional | Datex Ohmeda, Inc. | 03/02/2022SE |
| K190494 | Infant IncubatorFMZ · Traditional | Ningbo David Medical Device Co., Ltd. | 11/25/2019SE |
| K182859 | Babyleo TN500FMZ · Special | Dragerwerk AG & CO Kgaa | 02/22/2019SE |
| K182977 | Isolette 8000 PlusFMZ · Special | Draeger Medical Systems, Inc. | 11/21/2018SE |
| K172154 | Isolette 8000 plusFMZ · Traditional | Draeger Medical Sytems, Inc. | 04/19/2018SE |
| K162821 | Babyleo TN500FMZ · Traditional | Draegerwerk AG & CO Kgaa | 06/23/2017SE |
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| K102542 | Resusci Flow; Resusci Flow 104BTL · Traditional | 04/06/2011SE |
| K103828 | Bili-Therapy Spot TypeLBI · Traditional | 03/29/2011SE |
| K102227 | Infa Warmer IFMT · Traditional | 01/21/2011SE |
| K102226 | Dual Incu IFMZ · Traditional | 01/04/2011SE |
| K102279 | Incu IFMZ · Traditional | 12/29/2010SE |
| K061856 | V-2200 Infant IncubatorFMZ · Traditional | 09/28/2006SE |
Questions and answers
When was Neo-Servo I cleared by the FDA?
Neo-Servo I (K102710) received a 510(k) decision of Substantially Equivalent on December 22, 2010, 93 days after the submission was received.
What is the product code of K102710?
The FDA product code is FMZ – Incubator, Neonatal, a Class II (moderate risk) device regulated under 21 CFR 880.5400.