Drager Incubator 8000 Ic
FDA 510(k) K954204 · Drager, Inc.
510(k) numberK954204
Submission
- Device name
- Drager Incubator 8000 Ic
- Applicant
- Drager, Inc.
Chantilly, VA, US - Received
- September 6, 1995
- Decision date
- April 25, 1997
- 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
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| 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 |
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| K982789 | Medical Air Compressor, Model # 8413419BTI · Traditional | 10/29/1998SE |
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| K974176 | Babylog 8000 PlusCBK · Traditional | 06/17/1998SE |
| K971198 | Babytherm 8004 Babytherm 8010FMT · Traditional | 10/03/1997SE |
| K970165 | Evita 2 DuraCBK · Traditional | 08/26/1997ST |
| K961687 | Evita 4CBK · Traditional | 12/13/1996ST |
| K950853 | Optional Display and Software for Drager VentilatorsCBK · Traditional | 11/05/1996ST |
Questions and answers
When was Drager Incubator 8000 Ic cleared by the FDA?
Drager Incubator 8000 Ic (K954204) received a 510(k) decision of Substantially Equivalent on April 25, 1997, 597 days after the submission was received.
What is the product code of K954204?
The FDA product code is FMZ – Incubator, Neonatal, a Class II (moderate risk) device regulated under 21 CFR 880.5400.