V-2200 Infant Incubator
FDA 510(k) K061280 · Neoforce Group, Inc.
510(k) numberK061280
Submission
- Device name
- V-2200 Infant Incubator
- Applicant
- Neoforce Group, Inc.
Doylestown, PA, US - Received
- May 8, 2006
- Decision date
- June 27, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- FMZ – Incubator, Neonatal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5400
- Specialty
- General Hospital
Other 510(k)s with product code FMZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260326 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)FMZ · Traditional | Datex-Ohmeda, Inc. | 07/28/2026SE |
| 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 |
More from Draegerwerk AG & CO Kgaa
| 510(k) | Device | Decision |
|---|---|---|
| K110119 | Pressure ManometerCAP · Traditional | 06/10/2011SE |
| K103833 | Neopip Patient Circuit with PeepBYE · Traditional | 04/20/2011SE |
| K102649 | Neopop Infant Resuscitator with Flow MeterBTM · Traditional | 01/06/2011SE |
| K092085 | Ispira Resuscitation UnitBTL · Traditional | 10/07/2009SE |
| K072021 | Neopip Infant ResuscitatorBTM · Traditional | 09/12/2007SE |
| K070416 | Neopeep Neonatal Resuscitation Circuit with PeepBYE · Traditional | 05/29/2007SE |
Questions and answers
When was V-2200 Infant Incubator cleared by the FDA?
V-2200 Infant Incubator (K061280) received a 510(k) decision of Substantially Equivalent on June 27, 2006, 50 days after the submission was received.
What is the product code of K061280?
The FDA product code is FMZ – Incubator, Neonatal, a Class II (moderate risk) device regulated under 21 CFR 880.5400.