Dewette 2 Isolette Incubator Humidifier
FDA 510(k) K924297 · Air-Shields Vickers, Inc.
510(k) numberK924297
Submission
- Device name
- Dewette 2 Isolette Incubator Humidifier
- Applicant
- Air-Shields Vickers, Inc.
Hatboro, PA, US - Received
- August 26, 1992
- Decision date
- March 18, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K924679 | Oxycare(Tm) Oxygen Controller/MonitorKLK · Traditional | 02/21/1995SE |
| K912908 | Air-Shields Micro-Lite Phototherapy SystemLBI · Traditional | 12/13/1991SE |
| K912909 | Solair (TM) Infant Incubator Transparent Hood WarmFMZ · Traditional | 11/05/1991SE |
| K912910 | C100 Infant Incubator Shelf/Mount Rail SystemFMZ · Traditional | 10/30/1991SE |
| K904691 | Air-Shields Vickers Telescan Telecom Display SystHFM · Traditional | 02/19/1991SE |
| K903378 | Model C286 Isolette Infant IncubatorFMZ · Traditional | 10/15/1990SE |
| K895782 | Neonatal Incubator (Accessory)FMZ · Traditional | 12/07/1989SE |
| K884086 | C100 QT Variable Height Adjustment IncubatorFMZ · Traditional | 11/14/1988SE |
Questions and answers
When was Dewette 2 Isolette Incubator Humidifier cleared by the FDA?
Dewette 2 Isolette Incubator Humidifier (K924297) received a 510(k) decision of Substantially Equivalent on March 18, 1993, 204 days after the submission was received.
What is the product code of K924297?
The FDA product code is FMZ – Incubator, Neonatal, a Class II (moderate risk) device regulated under 21 CFR 880.5400.