Isolette 8000 plus
FDA 510(k) K172154 · Draeger Medical Sytems, Inc.
510(k) numberK172154
Submission
- Device name
- Isolette 8000 plus
- Applicant
- Draeger Medical Sytems, Inc.
Telford, PA, US - Received
- July 17, 2017
- Decision date
- April 19, 2018
- 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
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 |
| K162821 | Babyleo TN500FMZ · Traditional | Draegerwerk AG & CO Kgaa | 06/23/2017SE |
| K152814 | Giraffe OmniBed Carestation CS1FMZ · Special | Ohmeda Medical, A Division of Datex-Ohmeda,Inc.… | 03/17/2016SE |
More from Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company
| 510(k) | Device | Decision |
|---|---|---|
| K152407 | Infinity Delta, Infinity Delta XL, Infinity KappaMHX · Special | 09/23/2015SE |
Questions and answers
When was Isolette 8000 plus cleared by the FDA?
Isolette 8000 plus (K172154) received a 510(k) decision of Substantially Equivalent on April 19, 2018, 276 days after the submission was received.
What is the product code of K172154?
The FDA product code is FMZ – Incubator, Neonatal, a Class II (moderate risk) device regulated under 21 CFR 880.5400.